BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 10774679 · Received November 2, 2020

    Report

    Report Number
    2916596-2020-05243
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    October 12, 2020
    Report Date
    November 23, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS D4, H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF GASTROINTESTINAL (GI) BLEEDING AND SYNCOPE COULD NOT BE CONFIRMED. A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS AND THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6), WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU) LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE AND PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INTERNATIONAL NORMALIZED RATIO (INR) RANGE. INFORMATION REGARDING POSTOPERATIVE PATIENT CARE CAN ALSO BE FOUND WITHIN THIS IFU. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING 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 WAS ADMITTED ON (B)(6) 2020 FOR A SYNCOPAL FALL, SUSPECTED GASTROINTESTINAL BLEED (GIB), AND A DEGREE OF FAILURE TO THRIVE. THE PATIENT HAD A STANDING ORDER AT HIS COMMUNITY HOSPITAL TO TRANSFUSE FOR HEMOGLOBIN LOWER THAN 8. THE PATIENT HAD TRAUMA TO HIS HEAD FROM THE SYNCOPAL FALL. A COMPUTED TOMOGRAPHY (CT) SCAN FROM (B)(6) 2020 WAS NEGATIVE. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.6 WHICH WAS WITHIN NORMAL LIMITS FOR HIM. THE PATIENT'S ADMIT HEMOGLOBIN WAS 8. GASTROINTESTINAL HAD NOT SEEN THE PATIENT YET SO THERE WERE NO SCOPES. THE PATIENT WAS TRANSFUSED WITH 1 UNIT OF PACKED RED BLOOD CELLS (PRBC) ON (B)(6) 2020 FOR DOWNWARD HEMOGLOBIN TREND (FROM 8 TO 7.3 TO 6.9). THE PATIENT ALSO HAD A CARDIOMEMS DEVICE AS OF (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240413 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R