BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3022525 · Received March 21, 2013

    Report

    Report Number
    2916596-2013-00317
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. (B)(4). NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 8 MONTHS POST IMPLANT THE VAD COORDINATOR REPORTED THAT THE PT HAD EXPERIENCED AN UNEXPLAINED PUMP STOP. LOG FILES WERE REVIEWED BY THORATEC TECHNICAL SERVICES AND CONFIRMED THAT A PUMP STOP OCCURRED WHILE THE PT WAS CONNECTED TO THEIR POWER MODULE. THE MFR ALSO RECEIVED THE ATTACHED USER FACILITY REPORT (B)(4) FROM THE (B)(6) REGISTRY WHICH INDICATED THAT THE PT HAD ISCHEMIC COLITIS AND GASTRIC ISCHEMIA AT THE GREATER CURVATURE OF THE STOMACH DUE TO LVAD THROMBOSIS. THIS REPORTEDLY REQUIRED THE HOSP TO BE MORE AGGRESSIVE WITH ANTITHROMBOTIC THERAPY. A DECISION WAS MADE TO EXCHANGE THE DEVICE. THE PT RETURNED TO THE OPERATING ROOM THE FOLLOWING DAY FOR STERNAL CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116998 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114716

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention