BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8195971 · Received December 26, 2018

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    Report

    Report Number
    2916596-2018-05847
    Event Type
    Death
    Date Received
    December 26, 2018
    Date of Event
    November 21, 2018
    Report Date
    March 12, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OF DEVICE: 2 YEARS, 1 MONTH, 8 DAYS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT COMMUNICATED THAT THE PATIENT SUFFERED FROM A STROKE. ACCORDING TO THE ACCOUNT, THE STROKE IS A RIGHT TEMPORAL-OCCIPITAL HYPODENSITY AND LIKELY REPRESENTS A SUBACUTE STROKE. A CT SCAN WAS PERFORMED ON (B)(6) 2018 AND REVEALED AN R TEMPORAL-OCCIPITAL SUBACUTE CVA. THE PATIENT WAS ULTIMATELY EXPIRED DUE TO HEART FAILURE ON (B)(6) 2018 AND PUMP WAS NOT EXPLANTED. THE HMII LVAS IFU LISTS STROKE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM AND PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS "REPROTED" THAT PATIENT HAD A SUBACUTE STROKE ON (B)(6) 2018; HOWEVER, NO "ASSCOIATED" HEMORRHAGE WAS OBSERVED. PATIENT HAD AN OLD RIGHT BASAL GANGLIA LACUNAR INFARCT. PATIENT DECIDED TO WITHDRAW CARE. PATIENT EXPIRED ON (B)(6) 2018. NO AUTOPSY WAS PERFORMED AND THEREFORE, PUMP WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034589 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| L