BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 17175054 · Received June 21, 2023

    Report

    Report Number
    2916596-2023-03523
    Event Type
    Death
    Date Received
    June 21, 2023
    Date of Event
    May 27, 2023
    Report Date
    June 21, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN (B)(4) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE (IFU), REV. C, CONTAINS THE FOLLOWING INFORMATION: SECTION 1 OUTLINES POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, BLEEDING, STROKE, HEMOLYSIS, AND RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 STATES: ¿RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP.¿ THIS SECTION PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THERE IS A RISK OF BLEEDING. 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 PASSED AWAY DUE TO INTRAPARENCHYMAL HEMORRHAGE. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THE BLEEDING. THE EVENT WAS LIKELY RELATED TO ANTICOAGULATION STATUS, NORMAL HEMOLYSIS EXPECTED FROM THE HEARTMATE 3, AND POST-IMPLANT RIGHT VENTRICULAR ASSIST DEVICE (RVAD) REQUIREMENT. 1 UNIT OF PLATELETS WAS GIVEN. SURGICAL INTERVENTION WAS DISCUSSED BUT ULTIMATELY DECIDED AGAINST BY THE FAMILY DUE TO POOR PROGNOSIS. THE DEVICE OPERATED AS EXPECTED. THE DEVICE WAS NOT EXPLANTED, AND NO AUTOPSY WOULD BE PERFORMED. IT WAS LATER REPORTED THAT THE PATIENT HAD A MODERATELY DILATED RIGHT VENTRICLE AND MODERATELY REDUCED SYSTOLIC FUNCTION IDENTIFIED PRIOR TO SURGERY. THERE WERE NO DEVICE OR THERAPY RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO RIGHT HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031316 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8997270 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Death