BEUDAMED
    FDA Adverse Event Summary report: N

    HERO GRAFT

    MDR report key: 3081487 · Received April 29, 2013

    Report

    Report Number
    3006945290-2013-00021
    Date Received
    April 29, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 26, 2013
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A HERO GRAFT REVISION WAS PERFORMED APPROXIMATELY ONE AND A HALF YEARS FOLLOWING ORIGINAL IMPLANT IN RIGHT UPPER ARM. PATIENT, (B)(6) MALE, HAD MULTIPLE INTERVENTIONS (APPROXIMATELY SEVEN). THE SURGEON EXPOSED THE GRAFT, CONNECTOR, AND OC. HE PUT AN ANGLED GLIDEWIRE INTO RIGHT ATRIUM, REMOVED OC. HE HAD A DIFFICULT TIME AFTER DILATING INSERTING THE LONG SHEATH. HE FINALLY USED SHORT SHEATH WITH SUCCESS. HE THEN HAD DIFFICULTY WITH TUNNELING BOTH TUNNELS. THE SURGEON INDICATED THAT THE TROUBLE HE EXPERIENCED WITH THE SHEATH WAS DUE TO THE PATIENT'S ANATOMY AND NOT THE DEVICE. AFTER MUCH FRUSTRATION THE DEVICE WAS CONNECTED WITH SUCCESS. THE PATIENT HAD A LOT OF SCAR TISSUE OVER PREVIOUS HERO GRAFT. A LOWER EXTREMITY BRIDGING CATHETER WAS PLACED. PROCEDURE LASTED THREE HOURS. ADDITIONAL INFORMATION INDICATES THAT THE REVISION WAS NEEDED DUE TO MULTIPLE PERCUTANEOUS INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185759 HERO GRAFT VASCULAR GRAFT - PROSTHESIS DSY HEMOSPHERE, INC. HERO 1003

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other