BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 3896021 · Received June 13, 2014

    Report

    Report Number
    2916596-2014-00975
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    July 5, 2013
    Report Date
    May 15, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE DEVICE NOT BEING AVAILABLE FOR EVALUATION, A CORRELATION BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPIRED. AN AUTOPSY WAS NOT PERFORMED AND THE LVAD WAS NOT EXPLANTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A VENTRICULAR ASSIST DEVICE (VAD). PRIOR TO VAD IMPLANT, THE PATIENT WAS ADMITTED IN VENTRICULAR TACHYCARDIA. THE PATIENT UNDERWENT RESECTION OF A LEFT VENTRICULAR ANEURYSM AND AN LVAD AND RVAD WERE PLACED AS A BRIDGE TO RECOVERY DUE TO POST-CARDIOTOMY HEART FAILURE. THE RVAD WAS EXPLANTED 3 DAYS LATER. THE PATIENT EXPERIENCED A COMPLICATED POST-OPERATIVE COURSE AND EXPIRED APPROXIMATELY 6 WEEKS POST-IMPLANT. THE VAD COORDINATOR REPORTED THAT THE PATIENT'S VAD WAS FUNCTIONING, BUT THE FOLLOWING PATIENT RELATED CONDITIONS CONTRIBUTED TO THE PATIENT'S DEATH: GI BLEEDING, RIGHT VENTRICULAR DYSFUNCTION, MEDIASTINAL BLEEDING WITH CARDIAC TAMPONADE REQUIRING FOUR EMERGENT POST-OP EVACUATION PROCEDURES, DELAYED CHEST CLOSURE, ACUTE RESPIRATORY INSUFFICIENCY, DIALYSIS-DEPENDENT OLIGURIC RENAL FAILURE, MALNUTRITION, THROMBOCY TOPENIA, E.COLI URINARY TRACT INFECTION, ACUTE HEPATIC FAILURE, AND RIGHT VENTRICLE DYSFUNCTION. THE PATIENT HAD BEEN TRANSFERRED OUT OF INTENSIVE CARE ON POST-OPERATIVE DAY 33; BUT WAS TRANSFERRED BACK FOR GI BLEEDING WHICH RESULTED IN A SUBTOTAL COLECTOMY AND ILEOSTOMY AFTER WHICH LOWER GI BLEEDING CONTINUED. ON (B)(6) 2013 THE PATIENT LOST CONSCIOUSNESS DURING A HYPOTENSIVE EPISODE AND DID NOT REGAIN CONSCIOUSNESS AFTER BECOMING NORMOTENSIVE. AN URGENT HEAD CT SHOWED A RIGHT SIDED CEREBELLAR HEMORRHAGE WITH MASS EFFECT AND UPWARD TRANSTENTORIAL HERNIATION. THE PATIENT'S FAMILY ELECTED TO PROVIDE COMFORT CARE AND THE VAD WAS TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350484 VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 110578

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death