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Important Safety Information Thoracic Aortic Aneurysm (TAA)

Overview

This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at (800) 961-9055.

Valiant Thoracic Stent Graft with the Captivia Delivery System

Indications

The Valiant® Thoracic Stent Graft with the Captivia® Delivery System is intended for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including:

  • IIiac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;
  • Non-aneurysmal aortic diameter in the range of 18 – 42 mm; and
  • Non-aneurysmal aortic proximal and distal neck lengths ≥ 20 mm

Contraindications

The Valiant Thoracic Stent Graft with the Captivia Delivery System is contraindicated in:

  • Patients who have a condition that threatens to infect the graft.
  • Patients with sensitivities or allergies to the device materials.

Warnings and Precautions

The long-term safety and effectiveness of the Valiant Thoracic Stent Graft with the Captivia Delivery System has not been established. All patients should be advised that endovasculartreatment requires lifelong, regular follow-up to assess the integrity and performance of the implanted endovascular stent graft. Patients with specific clinical findings (for example, enlarging aneurysm, endoleaks, migration, or inadequate seal zone) should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. The Valiant Thoracic Stent Graft with the Captivia Delivery System is not recommended in patients who cannot undergo, or who will not be compliant with, the necessary preoperative and postoperative imaging and implantation procedures as described in the Instructions for Use. Strict adherence to the Valiant Thoracic Stent Graft sizing guidelines as described in the Instructions for Use is expected when selecting the device size. Sizing outside of this range can potentially result in endoleak, fracture, migration, infolding, or graft wear. The safety and effectiveness of the Valiant Thoracic Stent Graft with the Captivia Delivery System has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details

MRI Safety and Compatibility

Non-clinical testing has demonstrated that the Valiant Thoracic Stent Graft is MR Conditional. It can be scanned safely in both 1.5 T & 3.0 T MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use.

Adverse Events

Potential adverse events include, but are not limited to access failure, adynamic ileus, allergic reaction (to contrast, antiplatelet therapy, stent graft material), amputation, anaesthetic complications, aneurysm expansion, aneurysm rupture, angina, arrhythmia, arterial stenosis, atelectasis, blindness, bowel ischemia, bowel necrosis, bowel obstruction, branch vessel occlusion, breakage of the metal portion of the device, buttock claudication, cardiac tamponade, catheter breakage, cerebrovascular accident (CVA)/stroke, change in mental status, coagulopathy, congestive heart failure, contrast toxicity, conversion to surgical repair, death, deployment difficulties/failures, dissection/perforation/ rupture of the aortic vessel and/or surrounding vasculature, embolism, endoleak(s), excessive or inappropriate radiation exposure, extrusion/erosion, failure to deliver stent graft, femoral neuropathy, fistula (including aortoenteric,arteriovenous, and lymph), Gastrointestinal bleeding/complications, genitourinary complications, hematoma, hemorrhage/bleeding, hypotension/hypertension, infection and/or fever, insertion and removal difficulties, intercostal pain, intramural hematoma, leg/foot edema, lymphocele, myocardial infarction, neuropathy, occlusion – venous or arterial, pain/reaction at catheter insertion site, paralysis, paraparesis, paraplegia, paresthesia, peripheral ischemia, peripheral nerve injury, pneumonia, post-implant syndrome, procedural/post-procedural bleeding, prosthesis dilatation/infection/rupture/thrombosis, pseudoaneurysms, pulmonary edema, pulmonary embolism, reaction to anaesthesia, renal failure, renal insufficiency, reoperation, respiratory depression/failure, sepsis, seroma, shock, spinal neurological deficit, stent graft migration/misplacement/occlusion/ twisting/kinking, transient ischemic attack (TIA), thrombosis, tissue necrosis, vascular ischemia, vascular trauma, wound dehiscence, wound healing complications, and/or wound infection. Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Talent Thoracic Stent Graft with the Xcelerant Delivery System

Indications

The Talent™ Thoracic Stent Graft System is intended for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including:

  • iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;
  • non-aneurysmal aortic diameter in the range of 18 – 42mm; and
  • non-aneurysmal aortic proximal and distal neck lengths ≥ 20mm

Contraindications

The Talent Thoracic Stent Graft is contraindicated in:

  • Patients who have a condition that threatens to infect the graft.
  • Patients with sensitivities or allergies to the device materials.

Warnings and Precautions

  • Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient
  • The Talent Thoracic Stent Graft System should only be used by physicians and teams trained in vascular interventional techniques, including training in the use of this device. Specific training expectations are described in the Instructions for Use.
  • Always have a vascular surgery team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary
  • Do not attempt to use the Talent Thoracic Stent Graft with the Xcelerant Delivery System in patients unable to undergo the necessary preoperative and postoperative imaging and implantation studies as described in the Instructions for Use.
  • The Talent Thoracic Stent Graft System is not recommended in patients who cannot tolerate contrast agents necessary for intra-operative and post-operative follow-up imaging.
  • The Talent Thoracic Stent Graft System is not recommended in patients exceeding weight and/or size limits which compromise or prevent the necessary imaging requirements as described in the Instructions for Use.
  • Prior to the procedure, pre-operative planning for access and placement should be performed. Key anatomic elements that may affect successful exclusion of the aneurysm include severe neck angulation, short aortic neck(s) and significant thrombus and/or calcium at the arterial implantation sites. In the presence of anatomical limitations, a longer neck length may be required to obtain adequate sealing and fixation. See Instructions for Use.
  • The use of this device requires administration of radiographic agents. Patients with pre-existing renal insufficiency may have an increased risk of renal failure postoperatively
  • The safety and effectiveness of this device in the treatment of dissections have not been established. In the first 10 years of clinical experience (OUS-commercial and US-investigational), there were 39 reported events of retrograde dissection in patients. Of the 39 reported events, 33 patients had a pre-existing aortic dissection.
  • Inappropriate patient selection may contribute to poor device performance.
  • The long-term safety and effectiveness of this implant have not been established. All patients with endovascular aneurysm repair must undergo periodic imaging to evaluate the stent graft and aneurysm size. Significant aneurysm enlargement (>5 mm), the appearance of a new endoleak, or migration resulting in an inadequate seal zone should prompt further investigation and may indicate the need for additional intervention or surgical conversion.
  • Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms and/or endoleak. An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture.
  • The safety and effectiveness of the Talent Thoracic Stent Graft System has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details.

MRI Safety and Compatibility

Non-clinical testing has demonstrated that the Talent Thoracic Stent Graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use.

Adverse Events

Potential adverse events include (not arranged in any particular order): Amputation, Aneurysm Enlargement, Balloon rupture, Breakage of the metal portion of the device, Cardiac Failure/Infarction, Change in mental status, Conversion to open surgery, Death, Deployment difficulties, Edema, Embolization, Endoleak, Erectile Dysfunction, Erosion with fistula or pseudoaneurysm, Failure to deploy, Gastrointestinal complications, including: adynamic ileus, bowel (ileus, transient ischemic, infarction, necrosis), Graft twisting and/or kinking, Hemorrhage/Bleeding, Inaccurate placement, Infection and fever, Insertion and removal difficulties, Intercostal pain, Neurological complications, including: spinal cord ischemia with paraplegia, paraparesis and/or paresthesia, Cerebral Vascular Accidents (CVA), Transient Ischemic Attacks (TIA), neuropathy, and blindness, Prosthetic thrombosis, Pulmonary complications, Renal failure, Rupture of graft material, Ruptured vessel/aneurysm sac enlargement, Stent graft migration, Vascular complications including: thrombosis, thromboembolism, occlusion (arterial and venous), vessel dissection or perforation, collateral vessel occlusion, vascular ischemia, tissue necrosis, amputation, Wound healing complications

Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Talent Thoracic Stent Graft with the Captivia Delivery System

Indications

The Talent® Thoracic Stent Graft System is intended for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including:

  • iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;
  • non-aneurysmal aortic diameter in the range of 18 – 42mm; and
  • non-aneurysmal aortic proximal and distal neck lengths ≥ 20mm

Contraindications

The Talent® Thoracic Stent Graft is contraindicated in:

  • Patients who have a condition that threatens to infect the graft.
  • Patients with sensitivities or allergies to the device materials

Warnings and Precautions

  • Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient.
  • The Talent Thoracic Stent Graft System should only be used by physicians and teams trained in vascular interventional techniques, including training in the use of this device. Specific training expectations are described in the Instructions for Use.
  • Consider having a vascular surgery team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary.
  • Do not attempt to use the Talent® Thoracic Stent Graft with the Captivia Delivery System in patients unable to undergo the necessary preoperative and postoperative imaging and implantation studies as described in the Instructions for Use.
  • The Talent Thoracic Stent Graft System is not recommended in patients who cannot tolerate contrast agents necessary for intra-operative and post-operative follow-up imaging.
  • The Talent Thoracic Stent Graft System is not recommended in patients exceeding weight and/or size limits which compromise or prevent the necessary imaging requirements as described in the Instructions for Use.
  • Prior to the procedure, pre-operative planning for access and placement should be performed. See Instructions for Use for more detail. Key anatomic elements that may affect successful exclusion of the aneurysm include severe neck angulation, short aortic neck(s) and significant thrombus and/or calcium at the arterial implantation sites. In the presence of anatomical limitations, a longer neck length may be required to obtain adequate sealing and fixation. See Instructions for Use.
  • The use of this device requires administration of radiographic agents. Patients with preexisting renal insufficiency may have an increased risk of renal failure postoperatively.
  • The safety and effectiveness of this device in the treatment of dissections have not been established.
  • Inappropriate patient selection may contribute to poor device performance.
  • The long-term safety and effectiveness of this implant have not been established. All patients with endovascular aneurysm repair must undergo periodic imaging to evaluate the stent graft and aneurysm size. Significant aneurysm enlargement (>5 mm), the appearance of a new endoleak, or migration resulting in an inadequate seal zone should prompt further investigation and may indicate the need for additional intervention or surgical conversion.
  • Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms and/or endoleak. An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture.
  • Failure to align the connecting bar with the outer bend of the target vessel may increase the likelihood of endoleaks post implantation.
  • During general handling of the Captivia Delivery System, avoid bending or kinking the graft cover because it may cause the Talent® Thoracic Stent Graft to prematurely and improperly deploy.
  • The retrieval of the tip must be carefully monitored with fluoroscopic guidance to ensure that the tip does not cause the Talent® Thoracic Stent Graft to be inadvertently pulled down.

MRI Safety and Compatibility

Non-clinical testing has demonstrated that the Talent Thoracic Stent Graft is MR Conditional. It can be scanned safely in both 1.5T and 3.0T MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use.

Adverse Events

Potential adverse events include (not arranged in any particular order): Amputation, Aneurysm Enlargement, Balloon rupture, Breakage of the metal portion of the device, Cardiac Failure/Infarction, Conversion to open surgery, Death, Deployment difficulties, Edema, Endoleak, Erectile Dysfunction, Erosion with fistula or pseudoaneurysm, Failure to deploy, Gastrointestinal complications, including: adynamic ileus, bowel (ileus, transient ischemic, infarction, necrosis), Graft twisting and/or kinking, Hemorrhage/Bleeding, Inaccurate placement, Infection and fever, Insertion and removal difficulties, Intercostal pain, Neurological complications, including: change in mental status, spinal cord ischemia with paraplegia, paraparesis and/or paresthesia, Cerebral Vascular Accidents (CVA), Transient Ischemic Attacks (TIA), neuropathy, and blindness, Prosthetic thrombosis, Pulmonary complications, Renal failure, Rupture of graft material, Ruptured vessel/aneurysm, Stent graft migration, Vascular complications including: thrombosis, thromboembolism, occlusion (arterial and venous), vessel dissection or perforation, collateral vessel occlusion, vascular ischemia, tissue necrosis, Wound healing complications.

Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Archer Super Stiff Guidewire

Important Information

Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, suggested procedure, warnings and precautions.

Indications for Use

The Medtronic Archer 0.035 inch (0.89 mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.

Potential Adverse Events

The following complications may be associated with the use of guide wire devices; Air Embolism/Thromboembolism; Allergic Reactions; Amputation; Arteriovenous Fistula; Death; Embolism; Hematoma; Hemorrhage; Hemoglobinuria; Infection or Sepsis; Myocardial Ischemia and/or Infarction; Pseudoaneurysm; Stroke (CVA)/Transient Ischemic Attacks (TIA); Thrombus; Vessel Occlusion; Vessel Perforation, Dissection, Trauma, or Damage; Vessel Spasm; Wire Entrapment/Entanglement; and Foreign body/Wire Fracture.

Warnings and Precautions

This device is intended for use by physicians trained and experienced in diagnostic and interventional techniques.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for full product information. Please contact your local Medtronic sales representative for more information. For US distribution only.