BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAD

    MDR report key: 8539362 · Received April 23, 2019

    Report

    Report Number
    8539362
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 11, 2018
    Report Date
    March 19, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ELDERLY FEMALE GOT ADMITTED FOR ABDOMINAL PAIN AND FEVERS. H/O CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, LVAD IMPLANTATION WITH HM II (DT) 4 YEARS AGO WITH LAA EXCLUSION. PERIPHERAL VASCULAR DISEASE, HYPERTHYROID, METHAMPHETAMINE ABUSE, TOBACCO ABUSE, OBESITY. HMII LVAD WAS IMPLANTED 4 YEARS AGO. ASSESSMENT: ELEVATED LDH ON ADMISSION WITH UNEXPLAINED ANEMIA AND HF SYMPTOMS CONCERNING FOR LVAD THROMBOSIS. RAMP ECHO ON REASSURING IN THAT LV DECOMPRESSED NICELY. LIKELY SMALL, THROMBOSIS PRESENT IN LVAD. 4 DAYS LATER: LDH RISING 800->900, STARTED ON INTEGRILLIN IN ADDITION TO HEPARIN AND COUMADIN, REPORTED POWER SPIKE OVERNIGHT ONLY TRANSIENT THEN RESOLVED OVERNIGHT. 3 DAYS LATER: UFH XA GOAL INCREASED 0.4-0.5. 6 DAYS LATER: ACUTE INTRACRANIAL HEMORRHAGE MANIFESTED AS RIGHT ARM WEAKNESS/NEGLECT AND RIGHT HEMIANOPSIA. REVERSAL AGENTS GIVEN AND TAKEN TO OR FOR LEFT BURR HOLE. 5 DAYS LATER: PT DEVELOPED ACUTE ONSET WORSENING STROKE LIKE SYMPTOMS, CTA DEMONSTRATED ACUTE THROMBUS M1 SEGMENT OF R MCA, NO INTERVENTION, CONTINUED ON HEPARIN. WORSENING HA OVERNIGHT, STAT HEAD CT UNREMARKABLE IN CHANGES. HA TX WITH OXYCODONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332156 HEARTMATE II LVAD VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA