BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11091689 · Received December 29, 2020

    Report

    Report Number
    2916596-2020-06304
    Event Type
    Death
    Date Received
    December 29, 2020
    Date of Event
    December 9, 2020
    Report Date
    March 28, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(4), AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT DID NOT RECEIVE AN AUTOPSY; THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(4) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 09DEC2020. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS THE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. SECTION 7 ALARMS AND TROUBLESHOOTING DESCRIBES ALL ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE PATIENT OUTCOME THAT THE PATIENT EXPIRED ON (B)(6) 2020 DUE TO A SEVERE ANAPHYLACTIC REACTION TO PROTAMINE FOLLOWED BY SEVERE BRAIN DAMAGE. THE PATIENT HAD AN ANAPHYLACTIC REACTION TO PROTAMINE WITH MASSIVE HEMODYNAMIC DECREASE AND A DROP TO 0 LITERS PER MINUTE FLOW ON THE PUMP. THE PATIENT WAS PLACED BACK ON CARDIOPULMONARY BYPASS AND A RIGHT VENTRICULAR ASSIST DEVICE (RVAD) WAS INSTALLED. BOTH DEVICES WERE HEMODYNAMICALLY STABLE WHEN PLACED AND LATER IN THE INTENSIVE CARE UNIT (ICU). A COMPUTED TOMOGRAPHY (CT) SCAN THE NEXT DAY SHOWED SEVERE BRAIN DAMAGE WHICH WAS AT LEAST RELATED TO THE OUTCOME. NO AUTOPSY WAS PERFORMED. THE DEVICE WAS NOT EXPLANTED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550185 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 7273851

    Patients

    Seq Age Sex Outcome Treatment
    1 Death