BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19119151 · Received April 16, 2024

    Report

    Report Number
    2916596-2024-02019
    Event Type
    Death
    Date Received
    April 16, 2024
    Date of Event
    March 3, 2024
    Report Date
    June 12, 2024
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D1: CORRECTED. SECTION D4: CORRECTED CATALOG NUMBER AND UNIQUE DEVICE IDENTIFIER (UDI). MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS 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 LVAS IFU IS CURRENTLY AVAILABLE. ALTHOUGH THE REPORTED EVENTS WERE NOT DEVICE RELATED, THE IFU LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, RENAL DYSFUNCTION, AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT ALSO DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. 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 HAD INCREASED SHORTNESS OF BREATH AND CHRONIC KIDNEY DISEASE (CKD) AND PASSED AWAY DUE TO RIGHT VENTRICULAR FAILURE (RVF). IT WAS REPORTED THAT BOTH THE CKD AND RVF WERE PRE-EXISTING TO THE PATIENT'S IMPLANT WITH THE ONSET OF THE CKD BEING CONFIRMED TO BE ON (B)(6) 2020. THE ONLY TREATMENT PERFORMED PRIOR TO THE PATIENT PASSING AWAY WAS PALLIATIVE CARE. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED AND THE DEVICE OPERATED AS EXPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO RIGHT VENTRICULAR HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341002 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8179832 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death