Indications, Safety, and Warnings Penditure™ LAA Exclusion System

Possible complications related to the use of Penditure LAA exclusion system in combination with open heart surgery are: bleeding, tissue damage, thromboembolism, and pericardial effusion. For a complete listing of all indications, contraindications, precautions, and warnings, please refer to the Instructions for Use, which accompany each product.

• Penditure LAA Exclusion System
• Penditure™ LAA Exclusion System Selection Guide 

Penditure LAA Exclusion System

Indications

The Penditure LAA Exclusion System is indicated for the exclusion of the left atrial appendage of the heart, performed under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization, in this context, requires that the physician can see the heart directly, with or without assistance from a camera, endoscope, and so forth, or any other appropriate viewing technologies.

Contraindications

• Do not use this device if the patient has a known allergy to nitinol (nickel titanium alloy).
• Do not use this device as a contraceptive tubal occlusion device.

Potential Adverse Effects

Possible complications related to the use of Penditure™ LAA exclusion system in combination with open heart surgery are: bleeding, tissue damage, thromboembolism, and pericardial effusion. For a complete listing of all indications, contraindications, precautions, and warnings, please refer to the Instructions for Use, which accompany each product.

Warnings

Read all warnings, precautions, and instructions for use carefully before use. Failure to read and follow all instructions or failure to observe all stated warnings could cause serious injury to the patient.

• Before removing the device from the packaging, inspect the packaging and device for damage. Do not use the device if the use-by date has passed or if the device or package is damaged. Using an expired or damaged device could result in infection.
• The contents are supplied sterile using a gamma irradiation process. Do not use if the sterile barrier is damaged. If damage is observed, call a customer service representative.
• The device is single use only. Do not reuse, repurpose, or re-sterilize the device, as this could increase the risk of contamination of the device and cause the transmission of infectious diseases between patients and users. Contamination of the device may lead to illness, injury, or death.
• Do not actuate (open and close) the implant more than 5 times before final deployment. Doing so may result in displacement or incomplete exclusion of the LAA.
• Clip size should be determined by using the Penditure selection guide and referencing the Penditure selection guide instructions for use. Failure to correctly size or deploy the clip may result in improper exclusion of the LAA, displacement of the clip, or damage to adjacent patient anatomy.
• Before placing the clip onto the LAA, the physician should assess the suitability of the tissue for established closure techniques (surgical suturing, stapling, and so forth). Implanting the Penditure LAA Clip on tissue that is not suitable may cause tissue trauma or tearing.
• Do not use on a LAA less than 29 mm or greater than 50 mm when tissue is uncompressed. Doing so may result in incomplete exclusion or damage to adjacent anatomy.
• Failure to use the delivery system to reposition or remove the clip after deployment may result in tissue damage or tearing.
• Improper clip placement that allows blood flow into the LAA may result in incomplete exclusion or electrical isolation.
• The safety and effectiveness of this device in atrial rhythm control management, either alone or in combination with ablative treatment, has not been established.
• Dispose of the product and packaging in accordance with administrative, hospital, and local government policies.

Precautions

• Federal (USA) law restricts this device to sale by or on the order of a physician.
• Use of this product should be performed only by physicians with adequate training and familiarity with cardiac surgical procedures. Read all instructions carefully. Failure to properly follow these instructions may result in improper function of the device.
• Do not use a device that has been dropped or appears to be damaged. Instead, discard and replace such a device with a new device.
• Careful consideration of prior treatments (radiation therapy, for example) performed on the patient before surgery may result in changes to the tissue that may impact LAA exclusion. Physician judgement should be used to assess the suitability of the tissue before placement.
• Do not attempt to twist or manually manipulate the components on the distal end of the shaft. This may result in damage to the device. Excessive bending or kinking of the shaft may affect device performance.
• Bend the device by grasping only the shaft with fingers and thumbs. Do not grasp the distal end while bending as this could damage the device. Excessive bending or kinking of the shaft may adversely affect device performance.
• Do not attempt to twist the clip, as this may cause impaired function.
• Do not modify the Penditure LAA exclusion system. Medtronic makes no claim or representation regarding performance of this product if any modifications have been made to the device or clip.
• Evacuate thrombus from the LAA prior to clip application as required with other conventional LAA surgical techniques. Evaluation for the presence of thrombus should be performed at the physician’s discretion and using standard of care.
• To avoid suboptimal clip placement, position and deploy the clip only with adequate visualization of the LAA and adjacent anatomy.
• Minimize manipulation of the LAA and clip after clip deployment.
• It is recommended that the clip be deployed in a dry surgical field.
• Do not attempt to rotate the shaft without pushing the knob out of the locked position. Rotating the knob while in the locked position may damage the device.
• Only actuate the release trigger when the clip is properly positioned on the LAA. Pulling the release trigger allows for the release of the clip from the delivery system.
• Do not use the clip in temperatures below 68 °F. Application of the clip in temperatures below 68 °F may affect device performance.

Only physicians who are trained in standard cardiac surgical procedures can use this device.

For more information, contact your local Medtronic cardiac surgery representative. U.S. Customer Service: 1-800-328-1357.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions for Use.

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Penditure LAA Exclusion System Selection Guide

Indications

 The Penditure LAA exclusion system selection guide is intended to be used as an accessory to the Penditure LAA exclusion system

Contraindications

None known

Warnings

Read all warnings, precautions, and instructions for use carefully before use. Failure to read and follow all instructions, or failure to observe all stated warnings, could cause serious injury, vessel damage, complications at the puncture site, or death to the patient.

• Before removing the device from the packaging, inspect the packaging and device for damage. Do not use the device if the use-by date has passed or if the device or package is damaged. Using an expired or damaged device could result in infection.
• Do not apply excessive force when using the selection guide. Using excessive force may cause tissue damage.
• Use this device only as intended.

Precautions

• The Penditure LAA exclusion system selection guide is to be used only to assist with selecting the appropriate Penditure LAA exclusion system.
• Use of the selection guide should be limited to properly trained and qualified medical personnel.
• If the selection guide is dropped or damaged, do not use.
• Use caution when handling and interfacing with other devices.
• Do not bend the selection guide in the area of the size indication marks.
• Do not re-sterilize or reuse the selection guide. Single patient use only.