BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 24164091 · Received January 23, 2026

    Report

    Report Number
    2916596-2026-00532
    Event Type
    Death
    Date Received
    January 23, 2026
    Date of Event
    November 3, 2022
    Report Date
    January 23, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011712
    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

    BATCH REVIEW PERFORMED ON 12 JANUARY 2026. ANATOMICAL SHOULDER SYSTEM 04.01.0129 HC PEGGED GLENOID D 42 (K170910) LOT 2305367: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-AUG-2023. EXPIRATION DATE: 15-AUG-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0093 METAL HUMERAL HEAD D 46 (K170910) LOT 2338156: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2024. EXPIRATION DATE: 27-DEC-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE SURGEON REVISED AN ANATOMICAL SHOULDER SYSTEM TO A REVERSE TOTAL SYSTEM, WHICH IS A COMMON PRACTICE TO RESTORE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SUSPECTED DISLOCATION, BUT WITH ONLY INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE ANATOMICAL SHOULDER TO A REVERSE TOTAL SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227450 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524INT 5960042 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Death