BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 10095749 · Received May 28, 2020

    Report

    Report Number
    2916596-2020-02565
    Event Type
    Injury
    Date Received
    May 28, 2020
    Date of Event
    October 4, 2018
    Report Date
    August 13, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D7: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN (B)(6), AND THE REPORTED RIGHT HEART FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THE PATIENT WAS UPGRADED ON THE TRANSPLANT LIST DUE TO RIGHT HEART FAILURE AND WAS ULTIMATELY TRANSPLANTED ON (B)(6) 2018. THE HEARTMATE (HM) II LVAS IFU LISTS RIGHT HEART FAILURE AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE HMII LVAS. THIS DOCUMENT ALSO EXPLAINS THAT RIGHT HEART FAILURE CAN OCCUR POST-IMPLANT AND PROVIDES STRATEGIES FOR TREATING PATIENTS WHO EXPERIENCE RIGHT HEART FAILURE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSPLANT DUE TO RIGHT VENTRICULAR FAILURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561701 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 6036923 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R