BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP

    MDR report key: 10206799 · Received June 29, 2020

    Report

    Report Number
    2916596-2020-03060
    Event Type
    Death
    Date Received
    June 29, 2020
    Date of Event
    May 27, 2020
    Report Date
    September 30, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ORIGINALLY REPORTED UNDER MFR# 2916596-2022-02062 AS PART OF A HISTORICAL JMACS PATIENT REGISTRY REVIEW IN JAPAN THROUGH MCS ABBOTT JAPAN AFFILIATE. ON 26SEP2022 THE REVIEW OF FILES OF THIS EVENT TYPE WAS COMPLETED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A STROKE ORIGINATING FROM THE RIGHT HEMISPHERE ON (B)(6) 2020. SURGICAL TREATMENT WAS PERFORMED. ANTICOAGULANT TREATMENT AT THE TIME OF ONSET WAS HEPARIN. THE CAUSE OF THE HEMORRHAGIC STROKE WAS UNKNOWN. ON (B)(6) 2020, THE PATIENT PASSED AWAY. THE DEVICE WAS FUNCTIONING NORMALLY AT THE TIME OF DEATH. NO REMOVAL OF EQUIPMENT AFTER DEATH. NO DISSECTION PERFORMED. THE MAIN CAUSE OF DEATH WAS A DISORDER OF THE CENTRAL NERVOUS SYSTEM.

    Additional Manufacturer Narrative · 1

    THIS EVENT TOOK PLACE AT (B)(6) UNIVERSITY IN (B)(6). MANUFACTURER'S INVESTIGATION CONCLUSION: A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF STROKE COULD NOT BE CONCLUSIVELY DETERMINED. STROKE IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. STROKE HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RUSHED TO THE HOSPITAL DUE TO THE SUSPECTED STROKE ON (B)(6) 2020. THE PATIENT SUFFERED FROM A HEMORRHAGIC STROKE AND EXPIRED. THE PUMP COULD NOT BE RETURNED SINCE THE FAMILY DENIED PUMP EXPLANATION. IT WAS REPORTED THAT THERE WERE NO CHANGES IN PATIENT CONDITION AND ANTICOAGULATION THAT CONTRIBUTED TO THE EVENT. CT SCAN WAS TAKEN TO CONFIRM THE STROKE. THE PATIENT WAS IN COMA, AND NO AGGRESSIVE CARE WAS NOT TAKEN. THE DEATH WAS NOT RELATED TO THE DEVICE ACCORDING TO THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669440 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 104911JPN 6125156

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Hospitalization| D