BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10808650 · Received November 9, 2020

    Report

    Report Number
    2916596-2020-05511
    Event Type
    Injury
    Date Received
    November 9, 2020
    Date of Event
    September 21, 2020
    Report Date
    November 9, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED HEMATURIA AND SUSPECTED GASTROINTESTINAL (GI) BLEEDING COULD NOT BE DETERMINED THROUGH THIS EVALUATION. FOLLOWING THIS EVENT, THE PATIENT REMAINED ONGOING ON MLP-022127 UNTIL HE ULTIMATELY EXPIRED ON (B)(6) 2020 (REPORTED UNDER MFR # 2916596-2020-05264). THE DEVICE WAS NOT EXPLANTED AND IS NOT AVAILABLE FOR INVESTIGATION. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. MLP-022127 WAS SHIPPED ON 14JUL2020. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RECENT SUPRATHETAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR), HEMATURIA, AND SUSPECTED GASTROINTESTINAL BLEEDING (GIB). THE PATIENT WAS ADMITTED ON (B)(6) 2020 FOR GIB EVALUATION WHICH WAS NOT FELT TO BE URGENT AND THE PATIENT WAS DISCHARGED ON (B)(6) 2020 WITH LOVENOX BRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278871 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7550516 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R