BEUDAMED
    FDA Adverse Event Summary report: N

    HERO GRAFT

    MDR report key: 3233155 · Received July 18, 2013

    Report

    Report Number
    3006945290-2013-00022
    Date Received
    July 18, 2013
    Report Date
    May 2, 2013
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED IS ACCURATE OR HAS BEEN CONFIRMED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A FEW MONTHS AFTER IMPLANT THE EPTFE PORTION OF THE HERO GRAFT BEGAN TO LEAK AND IS ANEURYSMAL. THE HERO GRAFT WAS REVISED WITH A NEW OUTFLOW COMPONENT AND ARTERIAL GRAFT WITH A FLIXINE GRAFT. THE SURGEON EXPRESSED HIS CONCERNS WITH THE ARTERIAL GRAFT PORTION HAVING POOR DURABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336187 HERO GRAFT VASCULAR GRAFT - PROSTHESIS DSY HEMOSPHERE, INC. HERO 1002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other