BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14685536 · Received June 14, 2022

    Report

    Report Number
    2916596-2022-11626
    Event Type
    Death
    Date Received
    June 14, 2022
    Date of Event
    May 4, 2022
    Report Date
    June 16, 2022
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS (CARDIAC ARRHYTHMIA AND PATIENT OUTCOME) AND HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), REV. C CONTAINS THE FOLLOWING INFORMATION: SECTION 1 LISTS CARDIAC ARRHYTHMIA AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 LISTS CARDIAC ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO REOCCURRING VENTRICULAR TACHYCARDIA (VT) ON (B)(6) 2022. THE PATIENT HAD EXPERIENCED 20-30 IMPLANTED CARDIOVERTER DEFIBRILLATOR (ICD) SHOCKS A DAY. THEY DEVELOPED VT A COUPLE SAYS POST IMPLANT. THE PATIENT WAS TREATED WITH AN ABLATION AND BILATERAL STELLATE GANGLION BLOCK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED HYPOTENSION. ADDITIONALLY, IT WAS STATED THAT CAUSE OF DEATH WAS VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) STORMS THAT WERE UNCONTROLLED BY INTRAVENOUS (IV) MEDICATION AND ABLATION. THE PUMP WAS REPORTED TO HAVE BEEN OPERATING AS EXPECTED. NO AUTOPSY WAS PERFORMED, THE PUMP WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367187 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8108458 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death| R