BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO GRAFT

    MDR report key: 2880386 · Received December 19, 2012

    Report

    Report Number
    3006945290-2012-00013
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 19, 2012
    Report Date
    June 10, 2013
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    PMA / PMN Number
    K121532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE ARTERIAL GRAFT COMPONENT OF THE HERO GRAFT HAD DETERIORATED AFTER BEING IMPLANTED UNDER A YEAR. THE GRAFT WAS REMOVED DUE TO INFECTION CONCERN. IT WAS RETURNED FOR EVALUATION AND AN INVESTIGATION WAS PERFORMED. UPON VISUAL INSPECTION, A CLOT WAS FOUND IN THE GRAFT. THE EPTFE MATERIAL NEAR THE CONNECTOR WAS KINKED, AND DELAMINATION OF BEADING IN THE KINKED AREA WAS NOTED. A SMALL PORTION OF THE SILICONE LINING WITHIN THE OUTFLOW COMPONENT HAD TORN IN THE CONNECTOR AREA. THE OBSERVED DAMAGE WAS MOST LIKELY DUE TO PHYSICIAN HANDLING DURING IMPLANT AND/OR EXPLANT. IT IS IMPORTANT TO NOTE THAT THIS PATIENT WAS THE SURGEON'S FIRST HERO GRAFT IMPLANT, WHICH OCCURRED ON (B)(6) 2011. ACCORDING TO THE DIALYSIS THERAPY REPRESENTATIVE WHO WAS PRESENT AT IMPLANT, THE SURGEON WAS "STRUGGLING" WITH CONNECTING THE OUTFLOW COMPONENT TO THE CONNECTOR. IT IS POSSIBLE THAT THE OUTFLOW COMPONENT WAS FORCED ONTO THE CONNECTOR AT AN ANGLE OR SOMETHING WAS PINCHING THE OUTFLOW COMPONENT WHILE THE CONNECTOR WAS INSERTED. NEVERTHELESS, THERE WAS NO EVIDENCE OF "DETERIORATION" OR CANNULATION DAMAGE ON THE GRAFT MATERIAL.

    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

    EXPLANT DUE TO "INFECTION CONCERN" ONE YEAR POST-IMPLANT. INCIDENTAL FINDINGS OF DEVICE DAMAGE WERE NOTED AFTER EXPLANT, EPTFE MATERIAL NEAR THE CONNECTOR WAS KINKED WITH SOME BEADING DETACHED AND A SMALL AREA OF THE SILICONE LINING OF THE OUTFLOWCOMPONENT TORN UNDER AREA OF CONNECTOR. IT IS NOT CLEAR WHAT IS ALLEGED BY "INFECTION CONCERN" AS AN ACTUAL INFECTION WAS NOT REPORTED.

    Description of Event or Problem · 1

    EXPLANT DUE TO "INFECTION CONCERN" ONE YEAR POST-IMPLANT. INCIDENTAL FINDINGS OF DEVICE DAMAGE WERE NOTED AFTER EXPLANT, EPTFE MATERIAL NEAR THE CONNECTOR WAS KINKED WITH SOME BEADING DETACHED AND A SMALL AREA OF THE SILICONE LINING OF THE OUTFLOW COMPONENT TORN UNDER AREA OF CONNECTOR. IT IS NOT CLEAR WHAT IS ALLEGED BY "INFECTION CONCERN" AS AN ACTUAL INFECTION WAS NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other