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This tool is intended to help clinicians develop personalized management plans for HVAD patients. Content in this tool is based on recommendations in previously published Field Corrective Actions (FCAs) and is not intended to be prescriptive. As always, patient care decisions should be made by practitioners on a case-by-case basis, based on their clinical judgment.
This tool will be updated as needed, please bookmark and refer back to this page regularly.
Use this Planning Worksheet to develop a case-by-case assessment for your patients.
For complete information regarding patient management recommendations, please reference the Urgent Medical Device Communication letters via the Medtronic website:
For additional HVAD patient management resources, please consult the Instructions for Use and Patient Manual, and contact your local Medtronic Field Representative.
In consultation with the MCS Independent Practitioner Quality Panel, Medtronic recommends:
Mechanical circulatory support HVAD product advisories:
For additional HVAD patient management resources, please consult the Instructions for Use and Patient Manual, and contact your local Medtronic Field Representative.
Cumulative probability of experiencing a pump stop resulting in failure or delay to restart (by 3 years) [APR 2024] | ||
---|---|---|
High Risk Subgroups | 1 | 2.7% |
2 | 31.0% | |
3 | 4.8% | |
General HVAD population | 0.5% |
This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing these actions, including a controller exchange, should be made on a case-by-case basis taking into account the patient’s individual risk. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
This tool will be updated as needed, please bookmark and refer back to this page regularly.
Use this Planning Worksheet to develop a case-by-case assessment plan for your patients.
This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing any of these referenced actions, including a controller exchange, should be made on a case-by-case basis considering the patient’s individual risk and depending on a number of clinical factors assessed by practitioners. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
*Currently the Modified Controller with unapproved software is not available in all geographies. Use of the Modified Controller with unapproved software is with risk. Refer to the Physician Acknowledgement Form for potential risks associated with using the Modified Controller with the unapproved software.
This tool will be updated as needed, please bookmark and refer back to this page regularly.
If a bent pin is identified in a controller port, considerations for a controller exchange should include the invididual risk for delay or failure to restart following pump stop for the exchange.
This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing these actions, including a controller exchange, should be made on a case-by-case basis taking into account the patient’s individual risk. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
This tool will be updated as needed, please bookmark and refer back to this page regularly.
This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing these actions, including a controller exchange, should be made on a case-by-case basis taking into account the patient’s individual risk. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
This tool will be updated as needed, please bookmark and refer back to this page regularly.
This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing these actions, including a controller exchange, should be made on a case-by-case basis taking into account the patient’s individual risk. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
This tool will be updated as needed, please bookmark and refer back to this page regularly.
Upload and submit logfiles here.
This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing these actions, including a controller exchange, should be made on a case-by-case basis taking into account the patient’s individual risk. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
This tool will be updated as needed, please bookmark and refer back to this page regularly.