BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 19329931 · Received May 16, 2024

    Report

    Report Number
    2916596-2024-02783
    Event Type
    Death
    Date Received
    May 16, 2024
    Date of Event
    April 24, 2024
    Report Date
    September 5, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE (HM) II LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND THE REPORTED OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED DURING THIS EVALUATION. 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 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS STROKE, BLEEDING, HEMOLYSIS, AND DEATH AS ADVERSE EVENTS WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LVAS. SECTION 6, UNDER ¿ANTICOAGULATION¿, PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    B2: DATE OF DEATH ADDED B5: ADDITIONAL INFORMATION H1: UPDATED NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH HEMOLYSIS COMPLICATED BY GASTROINTESTINAL (GI) BLEEDING. THEIR LACTATE DEHYDROGENASE HAD CAME DOWN TO 300S AND BACK UP TO 800-900. THE PATIENT DENIES SYMPTOMS OF WORSENING HEART FAILURE ALTHOUGH THERE WAS VOLUME OVERLOADED FROM MULTIPLE BLOOD TRANSFUSIONS AND WAS BEING DIURESED. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED INTERMITTENT LOW FLOW EVENTS BETWEEN 02MAR2024 AND 20MAR2024.THERE DO NOT APPEAR TO BE ANY TYPE OF MECHANICAL CIRCULATORY SUPPORT(MCS) EQUIPMENT ISSUES CAUSING THESE EVENTS. THE LOW FLOW EVENTS SEEM TO BE A PATIENT HEMODYNAMICALLY RELATED ISSUE AND NOT A VENTRICULAR ASSIST DEVICE RELATED ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE GASTROINTESTINAL BLEEDING WAS CONFIRMED WITH POSITIVE HEMOCCULT AND WAS TREATED WITH SUPPORTIVELY WITH TRANSFUSION AND IV PROTON-PUMP INHIBITORS (PPIS). THE BLEEDING WAS REPORTED TO HAVE RESOLVED. NON-DEVICE RELATED CAUSE FOR HEMOLYSIS WAS NOT IDENTIFIED. TREATMENT FOR THE HEMOLYSIS WAS PERFORMED WITH ANTICOAGULATION AND DIURESIS. THE PATIENT THEN HAD AN ISCHEMIC STROKE AND THE FAMILY DECIDED TO OPT FOR COMFORT CARE. THE PATIENT PASSED AWAY ON (B)(6) 2024. DUE TO THE HEMOLYSIS AND STROKE, THE DEATH WAS CONSIDERED TO BE DEVICE OR THERAPY RELATED. THE DEVICE REPORTEDLY OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102055 THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 6337548 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization| D