BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19622234 · Received June 27, 2024

    Report

    Report Number
    2916596-2024-03898
    Event Type
    Death
    Date Received
    June 27, 2024
    Date of Event
    April 2, 2024
    Report Date
    July 29, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. SECTION D4: DEVICE MANUFACTURE DATE (H4) WAS NOT PROVIDED. THE PRIMARY UDI NUMBER IN D4 IS UPDATED WITH ALL OF THE CURRENT INFORMATION AVAILABLE. SECTION G2: CORRECTED. SECTION H8: CORRECTED. PILLAI, A. A., SINGH, K. S., MCNAMARA-DIORIO, K., MAXFIELD, A., SURPRENANT, D., GLUCK, J., HAMMOND, J. A., ALI, A. A., & JAISWAL, A. (2024). USE OF DIRECT ORAL ANTICOAGULANTS IN ADULTS WITH DURABLE LEFT VENTRICULAR ASSIST DEVICES. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 83(13), 299. HTTPS://DOI.ORG/10.1016/S0735-1097(24)02289-7 MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 DEVICES AND THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ABSTRACT TITLED ¿USE OF DIRECT ORAL ANTICOAGULANTS IN ADULTS WITH DURABLE LEFT VENTRICULAR ASSIST DEVICES¿ WAS RECEIVED. THE ARTICLE SOUGHT TO STUDY THE UTILITY AND SAFETY OF DIRECT ORAL ANTICOAGULANTS (DOACS) AND COMPARED OUTCOMES OF PATIENTS MAINTAINED ON WARFARIN VERSUS DOACS. THE STUDY INCLUDED A TOTAL OF 32 PATIENTS IMPLANTED WITH HEARTMATE 3 DEVICES; 22 PATIENTS WERE MAINTAINED ON WARFARIN AND 10 PATIENTS WERE MAINTAINED ON THE DOAC, APIXABAN. RESULTS OF THE STUDY SHOWED THAT ONE PATIENT FROM EACH GROUP EXPIRED. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, WERE NOT AVAILABLE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. 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 TITLED ¿USE OF DIRECT ORAL ANTICOAGULANTS IN ADULTS WITH DURABLE LEFT VENTRICULAR ASSIST DEVICES¿ IDENTIFYING HEARTMATE 3 (HM3) MAY BE RELATED WITH BLEEDING, STROKE, THROMBOSIS AND DEATH. THIS STUDY ESTABLISHED A PROTOCOL TO TRANSITION FROM WARFARIN TO DIRECT ORAL ANTICOAGULANTS (DOACS) IN ADULTS WITH HM3 LEFT VENTRICULAR ASSIST DEVICES (LVADS) AND COMPARED CHARACTERISTICS AND OUTCOMES OF PATIENTS MAINTAINED ON WARFARIN VERSUS DOACS. A TOTAL OF 32 HM3 PATIENTS WERE EVALUATED IN THIS RETROSPECTIVE STUDY. THE RESULTS REVEALED THAT 22 PATIENTS RECEIVED WARFARIN FOR 20260 DAYS ON LVAD SUPPORT VERSUS 10 ON APIXABAN FOR 7721 DAYS. 4 PATIENTS ON WARFARIN EXPERIENCED MAJOR UPPER OR LOWER GASTROINTESTINAL BLEEDING. NOTABLY, 2 PATIENTS WERE TRANSITIONED TO DOAC AFTER THESE BLEEDS. NO MAJOR BLEEDING EVENTS OCCURRED IN THE APIXABAN GROUP. PATIENTS ON APIXABAN HAD LOWER LIFETIME RATES OF BOTH MAJOR (0% VS 18.2%, P=0.2) AND ALL-CAUSE BLEEDING (20% VS 54.5%, P=0.1) THAN PATIENTS ON WARFARIN. PATIENTS ON APIXABAN HAD LOWER RATES OF VAD THROMBOSIS THAN THOSE ON WARFARIN (0% VS 13.6%, P=0.53) STROKE RISKS IN BOTH GROUPS WERE STATISTICALLY COMPARABLE. THIS STUDY HIGHLIGHTED THE SAFETY AND LOWER BLEEDING AND THROMBOSIS OF THE DOAC APIXABAN IN HM3 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806889 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death