BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22322016 · Received June 24, 2025

    Report

    Report Number
    2916596-2025-03996
    Event Type
    Death
    Date Received
    June 24, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 2, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: HEALTH EFFECT - CLINICAL CODE AND HEALTH EFFECT - IMPACT CODE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: IT WAS ORIGINALLY REPORTED THAT THE PATIENT EXPIRED DUE TO PNEUMONIA AND RIGHT HEART FAILURE. HOWEVER, FURTHER INFORMATION COMMUNICATED BY THE ACCOUNT REVEALED THAT THE RIGHT HEART FAILURE EXISTED PRIOR TO LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT, AND THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE RIGHT HEART FAILURE. THE PATIENT'S OUTCOME WAS NOT CONSIDERED TO BE DEVICE OR THERAPY RELATED, AND THE DEVICE OPERATED AS EXPECTED. IT WAS COMMUNICATED THAT THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2025 FOR NAUSEA AND VOMITING, AND RECURRENT PNEUMONIA (PNA) WITH PARAINFLUENZA VIRUS. THE PATIENT WAS ALSO NOTED TO HAVE EXPERIENCED WEIGHT GAIN AND DECOMPENSATION. THE PATIENT PASSED AWAY ON (B)(6) 2025 DUE TO PNA AND RIGHT HEART FAILURE (RHF). THE PATIENT HAD MODERATE TO SEVERE RIGHT HEART FAILURE PRIOR TO LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO RIGHT HEART FAILURE. PNA WAS NOT CAUSED BY RHF AND RHF DID NOT LEAD TO PNA. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED. THE DEVICE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426718 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 10107218 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Death