BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2974830 · Received February 18, 2013

    Report

    Report Number
    2916596-2013-00185
    Event Type
    Death
    Date Received
    February 18, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 25, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. THE ATTACHED USER FACILITY REPORT WAS RECEIVED FROM THE INTERMACS REGISTRY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: PATIENT ID: (B)(6). SERIAL # (B)(4), OTHER # VAD-9864. (B)(6).

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. AN INTERMACS REPORT WAS RECEIVED WHICH INDICATED THAT THE PT'S PUMP PARAMETERS WERE "ABNORMAL" (LOW PULSATILITY INDEX WITH NORMAL POWERS). EVENTUALLY, THE POWER INCREASED DRAMATICALLY. A TRANSTHORACIC ECHOCARDIOGRAM WAS CONDUCTED AND THIS TEST REVEALED THAT THERE WAS NO FLOW THROUGH THE PUMP. THE DEVICE TRACKING FORM WAS RECEIVED AND STATED: ON (B)(6) 2013, THE PT EXPIRED DUE TO MULTI SYSTEM ORGAN FAILURE AND CARDIOGENIC SHOCK. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: VAD PARAMETERS ABNORMAL, INITIALLY WITH LOW PI AND NORMAL POWERS. EVENTUALLY, POWERS INCREASED DRAMATICALLY, SUGGESTING THROMBOSIS. TTE REVEALED NO FLOW THROUGH THE VAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71348 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 104604

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death