BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC HEARTMATE 3

    MDR report key: 20343682 · Received October 1, 2024

    Report

    Report Number
    20343682
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    June 21, 2024
    Report Date
    June 24, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT NOW STATUS POST HEARTMATE 3. THE POST-OP COURSE COMPLICATED BY SUSPECTED INGESTION OF THROMBUS DURING IMPLANT ADMISSION WITH TIA WITHOUT RESIDUAL DEFICITS, BUT SMALL AREA ON CT HEAD IMAGING CONSISTENT WITH STROKE (WITH INR GOAL 2.5 TO 3.0). ALSO WITH PHEOCHROMOCYTOMA STATUS POST RESECTION [DATE REDACTED], AF WITH RAPID VENTRICULAR RESPONSE WITH PRIOR AVJ [ATRIOVENTRICULAR JUNCTION], HTN, GOUT, VIT D DEFICIENCY WHO PRESENTS AFTER CT DEMONSTRATED PARTIALLY OCCLUSIVE THROMBUS SEVERELY NARROWING LUMEN OF PROXIMAL OUTFLOW STENT GRAFT OF LVAD AS WELL AS WITH GI SYMPTOMS. NOW STATUS POST LEFT BRACHIAL ARTERY CUTDOWN AND STENT PLACEMENT OF LVAD OUTFLOW TRACT. RESUME HEPARIN GTT THIS EVENING AND WARFARIN TONIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40011 THORATEC HEARTMATE 3 VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male