BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21528522 · Received March 5, 2025

    Report

    Report Number
    2916596-2025-01285
    Event Type
    Death
    Date Received
    March 5, 2025
    Date of Event
    March 1, 2021
    Report Date
    April 10, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. ARSLAN, A., ÖZKAYA, Ö. G., AYTEMIZ, F., ALTAY, H., ÖZCAN, E. E., KÜÇÜKAKSU, D. S., BAKUY, V., KOZAN, Ö., & PEHLIVANOGLU, S. (2024). ORAL AMIODARONE AND PROPRANOLOL IN MAINTENANCE THERAPY OF POSTIMPLANTATION TACHYCARDIA: AN OBSERVATIONAL STUDY. MEDICINE, 103(28), E38839. HTTPS://DOI.ORG/10.1097/MD.0000000000038839. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    (B)(6). MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS WAS NOT RETURNED FOR EVALUATION. THE DEVICE SERIAL NUMBER WAS NOT PROVIDED AND WAS UNABLE TO BE DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS RIGHT HEART FAILURE, CARDIAC ARRHYTHMIA, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS RIGHT HEART FAILURE AS A POTENTIAL RISK/ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION (UNDER ¿RIGHT HEART FAILURE¿) ALSO OUTLINES INDICATIONS OF RIGHT HEART FAILURE AS WELL AS POSSIBLE TREATMENTS. SECTION 6 ALSO LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "ORAL AMIODARONE AND PROPRANOLOL IN MAINTENANCE THERAPY OF POST IMPLANTATION TACHYCARDIA: AN OBSERVATIONAL STUDY" THAT THE HM3 MAY BE RELATED TO RIGHT HEART FAILURE AND DEATH. CANNULA-RELATED VTS WERE OBSERVED IN >50% OF PATIENTS IN THE FIRST MONTH AFTER LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION. IN ADDITION TO CHRONIC VENTRICULAR SCARS, DE NOVO SCARS AT LVAD ENTRY CANNULATION SITES PROVIDED POTENTIAL SUBSTRATES FOR REENTRY ARRHYTHMIA. THUS, VT ORIGINATING FROM THE LATERAL WALL OF THE LEFT VENTRICLE (LV) IN THE EVENT OF NON-MYOCARDITIS, FROM THE LV SEPTUM DUE TO SARCOIDOSIS, AND FROM THE APICAL ANEURYSM-INDUCED SCAR TISSUE IN THE EVENT OF ANTERIOR MYOCARDIAL INFARCTION CAN OCCUR, AND NOT ALL VTS WERE CAUSED BY DE NOVO SCAR TISSUE. PROPRANOLOL IS WELL-TOLERATED BY PATIENTS WITH LVAD IMPLANTATION AND CAN BE ADMINISTERED IN HIGHER DOSES. THUS, PROPRANOLOL IS THE PREFERRED BETA-BLOCKER FOR THIS PATIENT GROUP. THIS MEDICATION CAN BE USED IN HIGH DOSES IN PATIENTS WITH LVAD IMPLANTATION, ACT ON THE CENTRAL NERVOUS SYSTEM RECEPTORS THROUGH ITS LIPOSOLUBLE CHARACTERISTICS, AND PROVIDE SIGNIFICANTLY REDUCED CATECHOLAMINE DISCHARGE BY NON SELECTIVE BETA-BLOCKADE. IT WAS REPORTED THAT 1 PATIENT DIED ONE DAY AFTER LVAD IMPLANTATION BECAUSE OF LOW RIGHT HEART OUTPUT. TABLE 2 REPORTED PATIENT 11, AS A 56-YEAR-OLD IMPLANTED WITH THE HEARTMATE 3 THAT PASSED AWAY ONE DAY LATER. THE PATIENT HAD A POSITIVE HISTORY OF ARRHYTHMIA, NONISCHEMIC HEART FAILURE AND MODERATE-SEVERELY DEPRESSED RIGHT VENTRICULAR FUNCTION. THE PATIENT WAS FOLLOWED UP AFTER NOT RECEIVING AMIODARONE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277094 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown Death