BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14167790 · Received April 21, 2022

    Report

    Report Number
    2916596-2022-10476
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    April 10, 2022
    Report Date
    April 21, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF GASTROINTESTINAL (GI) BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. GI BLEEDING HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED MELENA ON (B)(6) 2022; WARFARIN WAS WITHHELD UNTIL (B)(6) 2022. THE PATIENT VISITED THE EMERGENCY ROOM ON (B)(6) 2022 DUE TO POOR ORAL INTAKE AND DECREASED MENTAL STATUS. THE PATIENT WAS DIAGNOSED WITH HYPOVOLEMIC SHOCK. AN UPPER GASTROINTESTINAL ENDOSCOPY (EGD) AND SIGMOIDOSCOPY (SFS) WERE PERFORMED TO RULE OUT A GASTROINTESTINAL (GI) BLEED, AND BLOOD AND PLASMA TRANSFUSIONS WERE PERFORMED. A SOURCE OF THE PATIENT'S BLEEDING COULD NOT BE IDENTIFIED. THE PATIENT'S CONDITION WAS IMPROVING FOLLOWING THE TRANSFUSIONS AND THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772069 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 8011941 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H