BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10012084 · Received April 29, 2020

    Report

    Report Number
    2916596-2020-01981
    Event Type
    Death
    Date Received
    April 29, 2020
    Date of Event
    February 21, 2020
    Report Date
    May 4, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED RIGHT HEART FAILURE, RIGHT VENTRICLE THROMBUS, AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2020. INFORMATION PROVIDED INDICATED THAT THE PATIENT HAD RIGHT HEART FAILURE AND WAS IMPLANTED WITH ANOTHER MANUFACTURER'S RVAD. THE PATIENT SUBSEQUENTLY DEVELOPED A THROMBUS IN THE RIGHT VENTRICLE AND IN THE RVAD. THE HEARTMATE 3 LVAD REPORTEDLY OPERATED AS EXPECTED AND THE PATIENT'S DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED. IT WAS REPORTED THAT (B)(6) WOULD NOT BE RETURNED FOR EVALUATION. THE HEARTMATE 3 LVAS IFU LISTS RIGHT HEART FAILURE, PERIPHERAL THROMBOEMBOLIC EVENT, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 "PATIENT CARE AND MANAGEMENT" (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. SECTION 6 (UNDER CAUTION!) 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 LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP." IN ADDITION, SECTION 6 (UNDER "ANTICOAGULATION") CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY FOR PATIENTS USING THE DEVICE. SECTION 5 "SURGICAL PROCEDURES" (UNDER ¿PREPARING THE VENTRICULAR APEX SITE¿) INSTRUCTS TO INSPECT THE VENTRICULAR CHAMBER FOR MURAL THROMBI AND CROSSING TRABECULAE FOLLOWING REMOVAL OF THE CORE AND TO ADDRESS ONE OR BOTH, AS NEEDED. SECTION 5 (UNDER ¿IMPLANT PROCEDURES¿) ADDITIONALLY WARNS TO INSPECT THE VENTRICLE AND REMOVE ANY PREVIOUSLY FORMED CLOTS THAT MAY CAUSE EMBOLISM OR ANY TRABECULAE THAT MAY IMPEDE FLOW. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THERAPY DATE IS ESTIMATED. 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 EXPIRED. THE PATIENT HAD RIGHT HEART FAILURE AND WAS IMPLANTED WITH AN RVAD (BERLIN HEART EXCOR) AND DEVELOPED THROMBUS IN RV AND IN EXCOR PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475379 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 6855120

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BERLIN HEART EXCOR| BERLIN HEART EXCOR