BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15393732 · Received September 9, 2022

    Report

    Report Number
    2916596-2022-13679
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    April 2, 2021
    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, RENAL DYSFUNCTION, ASCITES AND PERIPHERAL EDEMA COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE PATIENT WAS READMITTED FROM (B)(6) 2021 DUE TO RIGHT HEART FAILURE, RENAL DYSFUNCTION, ASCITES AND PERIPHERAL EDEMA. A CARDIAC CATHETERIZATION WAS REPORTEDLY PERFORMED, BUT DIALYSIS WAS NOT REQUIRED. THE PATIENT REMAINS ONGOING ON (B)(4). NO ADDITIONAL RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE CURRENT HEARTMATE 3 LVAS IFU LISTS RIGHT HEART FAILURE AND RENAL DYSFUNCTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM IN SECTION 1, "INTRODUCTION." 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. 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) 2021 THE PATIENT HAD RIGHT HEART FAILURE AND RENAL DYSFUNCTION. ASCITES AND PERIPHERAL EDEMA WERE SEEN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM (B)(6) 2021. THE PATIENT'S MAXIMUM VALUE OF CREATININE WAS 5.01 MG/DL AND A CARDIAC CATHERIZATION WAS PERFORMED. DIALYSIS WAS NOT PERFORMED. THERE WAS SUSPECTED TO BE A LINK BETWEEN THE RIGHT HEART FAILURE, RENAL DYSFUNCTION AND THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361065 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7162257 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization| R