BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 21217186 · Received January 23, 2025

    Report

    Report Number
    2916596-2025-00563
    Event Type
    Death
    Date Received
    January 23, 2025
    Date of Event
    July 30, 2014
    Report Date
    January 23, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM THE INTERMACS REGISTRY. THE USER FACILITY NUMBER WAS NOT PROVIDED. THE INTERMACS IDENTIFIER IS LISTED IN H10. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT. H10: INTERMACS NYFL-100256(102244).

    Additional Manufacturer Narrative · 0

    SECTION H10: CORRECTION.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE PERFUSIONIST REPORTED THAT THE PUMP'S PERIODIC SPEED HAD DROPPED. ELEVATED POWER AND WIDE PULSE PRESSURE WERE OBSERVED. MINIMAL SYSTOLIC, BUT NO DIASTOLIC FLOW WAS OBSERVED ON ECHO. IT WAS ALSO REPORTED THAT AFTER EVERY BEAT, THE AORTIC VALVE WAS NOTED TO HAVE OPENED. TWO DAYS LATER THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) BECAUSE OF A RED HEART ALARM, INDICATING THAT THE PUMP HAD STOPPED WORKING. THE PATIENT ARRIVED IN THE OR WITH THE PUMP ON, BUT WITH NO FLOW. THE PATIENT RECEIVED A PUMP EXCHANGE. THE PATIENT EXPIRED ON (B)(6) 2014. ACCORDING TO THE VAD COORDINATOR, THE PATIENT'S EXPIRATION WAS NOT DEVICE RELATED AND THE PUMP FUNCTIONED AS INTENDED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE INTERMACS REGISTRY STATING: TEE CONFIRMED THROMBUS WITH HER AORTIC ROOT SUBSEQUENT EMBOLISM TO BOWEL AND LOWER EXTREMITIES. MIN SYSTOLIC AND NO DIASTOLIC FLOW THRU PUMP. PUMP OFF EVENT ON (B)(6) 2015 AT 2AM. ADDITIONAL INFORMATION ALSO INCLUDED INDICATED THAT THE PATIENT EXPIRED ON (B)(6) 2014 DUE TO WITHDRAWAL OF SUPPORT, SPECIFY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488676 THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Death