BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12713878 · Received October 28, 2021

    Report

    Report Number
    2916596-2021-05907
    Event Type
    Death
    Date Received
    October 28, 2021
    Date of Event
    October 3, 2021
    Report Date
    November 29, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS (VENTRICULAR TACHYCARDIA, RIGHT VENTRICULAR FAILURE, HYPOXEMIA, INTRACARDIAC SHUNT, PATIENT OUTCOME) AND HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (HM3 LVAS), SERIAL NUMBER (B)(6) COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT WAS S/P (STATUS POST) VT (VENTRICULAR TACHYCARDIA) ABLATION REQUIRING DOBUTAMINE FOR RV (RIGHT VENTRICULAR) SUPPORT. POST PROCEDURE DAY 0 THE PATIENT HAD RECURRENT VT AND ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) SHOCKS NECESSITATING CARDIOVERSION, WAS FOUND TO HAVE INTRACARDIAC SHUNTING WITH LARGE ATRIAL SEPTAL DEFECT (ASD) AND WORSENING RV FAILURE. THE PATIENT WAS TRANSITIONED TO COMFORT MEASURES AND ULTIMATELY EXPIRED ON (B)(6) 2021 DUE TO RV FAILURE, VT, HYPOXEMIA, AND INTRACARDIAC SHUNT. THE DEVICE REPORTEDLY OPERATED AS EXPECTED. THE CENTER REPORTED THAT HM3 LVAS, SERIAL NUMBER (B)(6) WOULD NOT BE RETURNED FOR EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (HM3 LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS CARDIAC ARRHYTHMIA, RIGHT HEART FAILURE, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HM3 LVAS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) 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.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO RIGHT VENTRICULAR (RV) FAILURE, VENTRICULAR TACHYCARDIA (VT), HYPOXEMIA, AND INTRACARDIAC SHUNT. THE PATIENT WAS STATUS POST VT ABLATION REQUIRING DOBUTAMINE FOR RV SUPPORT. POST PROCEDURE DAY 0 THE PATIENT HAD RECURRENT VT AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCKS NECESSITATED CARDIOVERSION. THE PATIENT WAS FOUND TO HAVE INTRACARDIAC SHUNTING WITH LARGE ATRIAL AND SEPTAL DEFECT AND WORSENING RV FAILURE. THE PATIENT WAS TRANSITIONED TO COMFORT MEASURES. THE DEVICE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611036 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 6903412 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Life Threatening| H| D