BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4122416 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01641
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 20, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE 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.

    Additional Manufacturer Narrative · 1

    THE REPORT OF A KINKED SEALED OUTFLOW GRAFT COULD NOT BE CONFIRMED AS PHOTOGRAPHS OF THE OUTFLOW GRAFT AND THE ACTUAL LVAD WERE NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE SURGEON TOOK PHOTOGRAPHS OF THE SEALED OUTFLOW GRAFT; HOWEVER, TO DATE, THE PHOTOS HAVE NOT BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS EXPLANTED DUE TO PT RECOVER, AND PT'S CHOICE. UPON EXPLANT HOWEVER, THERE WAS A KINK NOTICED ON THE OUTFLOW GRAFT; NO SPECIFIC ACTION WAS TAKEN. THE HOSPITAL WOULD LIKE THE PUMP EVALUATED. THE PT IS STABLE IN THE INTENSIVE CARE UNIT (ICU) POST EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579253 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 119680

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention