BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC ARTERIAL CANNULAE

    MDR report key: 2496013 · Received March 16, 2012

    Report

    Report Number
    2916596-2012-00226
    Event Type
    Injury
    Date Received
    March 16, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 16, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. 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 BIVENTRICULAR SUPPORT. IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPERIENCED BLEEDING WHICH REQUIRED RE-OPERATION. IT WAS REPORTED BY THE SURGEON THAT THE BLEEDING WAS FOUND TO ORIGINATE FROM THE ARTERIAL CANNULAE GRAFT MATERIAL. THE LVAD ARTERIAL CANNULAE WAS FOUND TO BE LEAKING THRU THE GRAFT, NEAR THE BLACK LINE OF THE GRAFT, ABOUT THREE INCHES FROM THE AORTIC ANASTOMOSIS TO THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC ARTERIAL CANNULAE DSQ: VENTRICULAR ASSIST SYSTEM ARTERIAL CANNULAE DSQ THORATEC CORP. 100121 101380

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention