BEUDAMED
    FDA Adverse Event Death Summary report: N

    TCI IP LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 155691 · Received March 11, 1998

    Report

    Report Number
    1218444-1998-00005
    Event Type
    Death
    Date Received
    March 11, 1998
    Date of Event
    February 7, 1998
    Report Date
    February 10, 1998
    Manufacturer
    THERMO CARDIOSYSTEMS INC.
    Product Code
    DSQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    021098-PHYSICIAN THOUGHT THERE MIGHT BE A TECHNICAL PROBLEM SINCE PATIENT EXPERIENCED ACUTE FLOW DROP. PATIENT TAKEN TO O.R.; AIR WAS "EVERYWHERE" AND "IN THE AORTA" DECISION MADE TO TERMINATE EVERYTHING. 021198-PHYSICIAN STATED THAT PATIENT HAD A BSA OF 1.8 AND A LARGE HEART. THE DEVICE WAS IN THE NORMAL POSITION. THE INLET MAY BE TOO HIGH, THE UMBILICUS WAS HIGH. PERC LINE PUT RIGHT OF UMBILICUS. SEWING RING ATTACHED TO INFLOW CONDUIT WITH ATTACHED BLUE THREAD, THE BAND AND UMBILICAL TAPE. PATIENT TAMPONADE. WHEN OPENED IN O.R., AIR SUCKED. INLET CONDUIT FOUND TO BE OUT OF SEWING RING. DEVICE WAS NOT ANCHORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TCI IP LEFT VENTRICULAR ASSIST SYSTEM Implant LEFT VENTRICULAR ASSIST DEVICE (LVAD) DSQ THERMO CARDIOSYSTEMS INC. 1000A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death