BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16248025 · Received January 26, 2023

    Report

    Report Number
    2916596-2023-00580
    Event Type
    Death
    Date Received
    January 26, 2023
    Date of Event
    January 2, 2023
    Report Date
    January 26, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE PATIENT OUTCOME, AS WELL AS A DIRECT CORRELATION TO THE HEARTMATE 3 LVAS, SERIAL NUMBER MLP-011603, COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE CAUSE OF DEATH IS UNKNOWN. DUE TO PATIENT PRIVACY LAWS THE MANAGING HOSPITAL WOULD NOT COMMUNICATE PATIENT OUTCOME INFORMATION. BASED ON A REVIEW OF AVAILABLE PATIENT¿S RECORD AND A REQUEST FOR PATIENT OUTCOME, THERE WERE NO DEVICE ISSUES AT THE TIME OF THE PATIENT OUTCOME. THE OUTCOME WAS NOT CONSIDERED TO BE DEVICE OR THERAPY RELATED. NO AUTOPSY WAS PERFORMED. THE DEVICE WAS NOT EXPLANTED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THERE WERE NO ALARMS FOR THIS EVENT. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-011603 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU, REV. G IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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 ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109419 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 6572175

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death