BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3181307 · Received June 12, 2013

    Report

    Report Number
    2916596-2013-00749
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT AFTER APPROX 8 MONTHS OF SUPPORT ON THE LVAD, THE INFLOW CANNULA WAS MISALIGNED AND FLOW WAS COMPROMISED. THE PT'S LACTATE DEHYDROGENASE (LDH) BEGAN TO ELEVATE AND HEMATURIA WAS PRESENT. THE HOSP MADE A DECISION TO EXCHANGE THE LVAD DUE TO SUSPECTED THROMBUS RELATED TO INFLOW CANNULA MALPOSITION. AN INTERMACS REPORT WAS ALSO RECEIVED, WHICH INDICATED THAT THE PT ALSO HAD SYMPTOMATIC PULSATILITY INDEX (PI) EVENTS WITH PRESYNCOPE AND DECREASING SPEEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267107 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 118139

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention