BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15394972 · Received September 9, 2022

    Report

    Report Number
    2916596-2022-13689
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    December 1, 2020
    Report Date
    September 9, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ORIGINALLY REPORTED UNDER MFR# 2916596-2022-01919 AS PART OF A HISTORICAL JMACS PATIENT REGISTRY REVIEW IN JAPAN THROUGH MCS ABBOTT JAPAN AFFILIATE. ON 06SEP2022 THE REVIEW OF FILES OF THIS EVENT TYPE WAS COMPLETED. MANUFACTURE¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD), SERIAL NUMBER (B)(4), AND THE REPORT OF RIGHT HEART FAILURE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS COMMUNICATED THAT THE PATIENT WAS READMITTED FROM (B)(6) 2020 TO (B)(6) 2020 DUE TO EXACERBATION OF RIGHT HEART FAILURE SYMPTOMS. A CARDIAC CATHERIZATION AND ADDITIONAL TESTING WERE PERFORMED. THE PATIENT'S ORAL MEDICATION WAS ADJUSTED AND PUMP SPEED WAS INCREASED. THE PATIENT REMAINS ONGOING ON (B)(4). NO ADDITIONAL RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE CURRENT HEARTMATE 3 LVAS IFU LIST RIGHT HEART FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, "INTRODUCTION." ADDITIONALLY, ¿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. (UNDER ¿RIGHT HEART FAILURE¿) ALSO OUTLINES INDICATIONS OF RIGHT HEART FAILURE, AS WELL AS POSSIBLE TREATMENTS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(4) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT WAS READMITTED DUE TO EXACERBATION OF RIGHT HEART FAILURE SYMPTOMS FROM (B)(6) 2020 TO (B)(6) 2020. THE PATIENT RECEIVED A CARDIAC CATHERIZATION, LAMP TEST AND ORAL ADJUSTMENT. THE SPEED OF THE PUMP WAS ADJUSTED. THE RELATIONSHIP BETWEEN THE EXACERBATION OF RIGHT HEART FAILURE SYMPTOMS AND THIS PRODUCT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579199 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7319416 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention| H