BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERO GRAFT

    MDR report key: 4916326 · Received July 15, 2015

    Report

    Report Number
    1063481-2015-00111
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 10, 2015
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    DSY
    PMA / PMN Number
    K124039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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 FROM THE REPRESENTATIVE, "HERO GRAFT PLACEMENT ON (B)(6) YR OLD FEMALE. INTERVENTIONAL RADIOLOGY (IR) IMPLANTED VENOUS OUTFLOW COMPONENT (VOC SUCCESSFULLY). THE SURGEON TOOK OVER TO IMPLANT AV GRAFT AND COMPLETE THE HERO GRAFT PROCEDURE. HE ATTACHED THE CLAMPED VOC TO THE AV GRAFT PRIOR TO TUNNELING THE VOC TO THE DELTO-PECTORAL GROVE (DPG). HE THEN MADE AN INCISION AT THE DPG AND USED A HEMOSTAT THE TUNNEL THE CONNECTED COMPONENTS, REPOSITIONING TWICE TO AVOID LINKING AND TWISTING. FOLLOWING THE SUCCESSFUL TUNNEL, THE SURGEON REMOVED THE CLAMP; NO BLOOD BACK FLOWED IN THE GRAFT. I SUGGESTED POSSIBLE KINKING OF THE AV GRAFT AT THE CONNECTION PER MY OBSERVATION DURING TUNNELING. I EXPLAINED THAT THE AV GRAFT WAS DESIGNED TO BE REPLACED, AND THEREFORE COULD BE DISCONNECTED FROM THE VOC IN ASSESS POSSIBLE KINKING AND TROUBLESHOOT WHY THERE WAS NO BLOOD BACKFLOW. THE SURGEON ATTEMPTED TO DISCONNECT THE AV GRAFT FROM THE VOC. WHEN PULLING APART, THE GRAFT UNDERNEATH THE CLEAR CONNECTOR COVER DISCONNECTED AWAY FROM THE CONNECTOR. THE SURGEON TRIED TO PUSH THE GRAFT BACK UNDER THE CLEAR COVER. I SUGGESTED REPLACING THE AV GRAFT WITH A NEW COMPONENT. THE SURGEON CONTINUED TO TUNNEL THE FULL HERO GRAFT. HE THEN EXPRESSED CONCERN ABOUT THE CONNECTOR AND I AGAIN SUGGESTED REPLACING THE AV GRAFT. HE AGREED AND I OBTAINED A NEW AV GRAFT COMPONENT FROM OR SUPPLY. THE SURGEON EXPLANTED LOT# H14AV015 REF# HERO 1002. HE THEN IMPLANTED LOT# H14AV015 REF# HERO 1002 EXPIRATION 2016-03-20. AFTER IMPLANTATION, THE SURGEON FLUSHED THE HERO GRAFT WITH HEP SALINE AND ASSESSED FOR BLOOD BACK FLOW, WHICH WAS OBTAINED. HE THEN CONTINUED WITH THE REMAINDER OF THE CASE." ADDITIONAL INFORMATION FROM THE REP INDICATED THAT THE CAUSE OF THE KINKING WAS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461063 HERO GRAFT VASCULAR GRAFT DSY CRYOLIFE, INC. HERO 1002 H14AV015

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR