BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 23301060 · Received October 15, 2025

    Report

    Report Number
    2916596-2025-06396
    Event Type
    Death
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 15, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO A FALL AND SPINAL FRACTURE WHILE WORKING AT HOME ON A DRILL PRESS. IT WAS COMMUNICATED THAT THE PATIENT LIFTED THIS UP TO PLACE IT ON THEIR FLOOR AND FELT A TWINGE OF PAIN IN THEIR BACK. THE PATIENT LATER BENT OVER TO PICK UP THE PACK FOR THEIR LEFT VENTRICULAR ASSIST DEVICE (LVAD) CASE AND EXPERIENCED SUDDEN ONSET OF PAIN. THE PATIENT HAD SUCH SEVERE PAIN THAT THEY WENT TO THE EMERGENCY DEPARTMENT AND HAD A COMPUTED TOMOGRAPHY (CT) SCAN OF THE LUMBAR SPINE, WHICH SHOWED EVIDENCE OF NONDISPLACED ANTERIOR SUPERIOR ENDPLATE FRACTURE OF THE L5 VERTEBRAL BODY. IT WAS RECOMMENDED THAT THE PATIENT BE PLACED IN A LUMBAR-SACRAL ORTHOSIS (LSO) BRACE AND FOLLOW-UP OUTPATIENT. IT WAS COMMUNICATED THAT THE PATIENT FELL AGAIN OVER ONE MONTH LATER, WAS ADMITTED TO THE HOSPITAL, AND SUBSEQUENTLY DISCHARGED TO HOSPICE. IT WAS REPORTED THAT THE PATIENT WAS TIRED OF LIVING WITH WEAKNESS AND PAIN AND WAS TRANSITIONED TO COMFORT MEASURES ONLY. IT WAS REPORTED THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED, AND THE DEVICE PARAMETERS WERE WITHIN NORMAL LIMITS FOR THIS PATIENT. AN AUTOPSY WAS NOT PERFORMED, AND THE PUMP WAS NOT EXPLANTED FOR EVALUATION. THE HEARTMATE 3 LVAS IFU, REV. D IS CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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 SUFFERED A FALL AND SPINAL FRACTURE IN AUGUST WHILE WORKING AT HOME ON A DRILL PRESS. THE PATIENT LIFTED THIS UP TO PLACE IT ON THEIR FLOOR AND FELT SEVERE PAIN ON THEIR BACK WHEN THEY BENT OVER TO PICK UP THE PACK FOR THEIR LEFT VENTRICULAR ASSIST DEVICE (LVAD) CASE. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT (ED) AND HAD A COMPUTED TOMOGRAPHY (CT) OF THE LUMBAR SPINE WHICH SHOWED EVIDENCE OF NONDISPLACED ANTERIOR SUPERIOR ENDPLATE FRACTURE OF THE L5 VERTEBRAL BODY. THE PATIENT WAS PLACED IN AN LSO BRACE. THE PATIENT FELL ON (B)(6) 2025 AND WAS ADMITTED TO THE HOSPITAL. SUBSEQUENTLY, THE PATIENT WAS DISCHARGED TO HOSPICE. THE PATIENT WAS TIRED OF LIVING WITH WEAKNESS AND PAIN, SO THE PATIENT WAS TRANSITIONED TO COMFORT MEASURES ONLY (CMO). THE PATIENT PASSED AWAY ON (B)(6) 2025. THE DEVICE WAS NOT EXPLANTED, NO AUTOPSY WAS PERFORMED, THE OUTCOME WAS NOTED NOT TO HAVE BEEN DEVICE OR THERAPY RELATED, AND THE DEVICE PARAMETERS WERE NOTED TO HAVE BEEN WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994127 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US L00000633 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death