BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10102858 · Received May 29, 2020

    Report

    Report Number
    2916596-2020-02563
    Event Type
    Injury
    Date Received
    May 29, 2020
    Date of Event
    May 1, 2020
    Report Date
    May 29, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), AND THE REPORT OF RESPIRATORY FAILURE AND STROKE COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, A SPECIFIC CAUSE FOR THE REPORT OF SEPSIS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS IFU LISTS STROKE, BLEEDING, RESPIRATORY FAILURE, AND SEPSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THIS DOCUMENT ALSO PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE, AS WELL AS CONSIDERATIONS FOR WHEN THERE IS A RISK OF BLEEDING. THIS IFU, AS WELL AS THE HM3 LVAS PATIENT HANDBOOK, ALSO PROVIDES INFORMATION REGARDING HOW TO PREVENT INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2020 WITH RESPIRATORY FAILURE AND SEPSIS. THE PATIENT HAD A MASSIVE ISCHEMIC STROKE (LARGE MULTIFOCAL INFARCTS WITH HEMORRHAGIC CONVERSION) ON (B)(6)2020. THEY WERE NOT ON ANTICOAGULATION AT THE TIME. ON ADMISSION THEIR INTERNATIONAL NORMALISED RATIO (INR) WAS 3.7 G/DL, PEAK 5.9 G/DL ON (B)(6) 2020, AND 2.2 G/DL ON DAY OF STROKE. BLOOD CULTURES FROM (B)(6) 2020 SHOWED ENTEROCOCCUS FAECALIS BUT THE SOURCE OF THE INFECTION WAS NOT IDENTIFIED. THE PATIENT'S FAMILY DECIDED TO WITHDRAW CARE (B)(6) 2020. IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD BEEN UNRESPONSIVE FOR 24 HOURS FOLLOWING CESSATION OF A SEDATIVE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S STROKE WAS CONFIRMED WITH A HEAD COMPUTED TOMOGRAPHY (CT). THE PATIENT'S DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED AND THE DEVICE OPERATED AS EXPECTED. THE DEVICE WAS NOT EXPLANTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563846 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 6949737 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L