BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO GRAFT

    MDR report key: 2903497 · Received January 9, 2013

    Report

    Report Number
    3006945290-2013-00003
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    July 29, 2013
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    PMA / PMN Number
    K121532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE SURGEON STATED THAT THE HERO ARTERIAL GRAFT COMPONENT WOULD NOT INCORPORATE FOR APPROXIMATELY 10 PATIENTS EVEN AFTER 30 DAYS. THE GRAFT WAS IMPLANTED VIA VECTRA TUNNELING. THE INCIDENCES WERE ALL NOTICED DURING OPEN DECLOTS OF THE ACTUAL GRAFTS. NONE OF THE PATIENTS HAD PREVIOUS ISSUES WITH GRAFT INCORPORATION. THE SURGEON SWITCHED FROM USING A GORE TUNNELER TO A KELLY-WICK TUNNELER TO SEE IF THIS WAS A CAUSE OF TRAUMA TO THE PATIENT; HOWEVER, THE ISSUE STILL AROSE. IN EACH OF THE SITUATIONS, THE GRAFTS WERE EXCISED JUST PAST THE CONNECTORS AND REPLACED WITH VECTRA GRAFTS. THE SURGEON STATED THAT HE PREFERS VECTRA GRAFTS BECAUSE THEIR EARLY STICK PROPERTIES WHICH AVOIDS THE NEED FOR A BRIDGING CATHETER. GRAFTS CAN FAIL TO INCORPORATE FOR A NUMBER OF REASONS, SUCH AS IMPLANT TECHNIQUE OR SEROMA. IT IS POSSIBLE THAT THE GRAFTS FAILED TO INCORPORATE DUE TO IMPLANT TECHNIQUE AS THE SAME SURGEON IMPLANTED THE HERO GRAFT IN ALL 10 REPORTED CASES. IMPROPER GRAFT HANDLING DURING IMPLANT OR USING TOO LARGE OF A TUNNELER AFFECTS TISSUE INGROWTH AND HEALING. IMPLANTING AN AV ACCESS GRAFT REQUIRES PROPER, DELICATE TUNNELING TECHNIQUE TO AVOID AN EXCESSIVELY LARGE TUNNEL THAT CAN LEAD TO DELAYED TISSUE INCORPORATION AND HEALING. WHEN A SURGEON USES AN INSTRUMENT THAT ACCURATELY MATCHES THE DIAMETER OF THE TUNNEL WITH THE DIAMETER OF THE INTENDED GRAFT, LESS TISSUE IS DISRUPTED. AS RESULT, TISSUE INGROWTH IS ENHANCED AND HEALING IS QUICKER WITH LESS PATIENT DISCOMFORT. IT IS ALSO POSSIBLE THAT A SEROMA COULD HAVE AFFECTED THE INCORPORATION OF THE GRAFT. THE HERO GRAFT INSTRUCTIONS FOR USE (IFU) LISTS SEROMA AS A POTENTIAL COMPLICATION. ACCORDING TO A REVIEW OF THE RELEVANT LITERATURE, THE LITERATURE RATE OF SEROMA IN AVGS IS 3.6%; HOWEVER, THERE WERE NO REPORTS FOR SEROMA OR NON-INCORPORATING GRAFT IN CLINICAL TRIALS FOR THE HERO GRAFT. THERE WERE (B)(4) IMPLANTS REPORTED FOR THE FACILITY ASSOCIATED WITH THIS EVENT. NO PREVIOUS NON-INCORPORATING EVENTS HAVE BEEN REPORTED FROM THIS FACILITY WHICH RESULTS IN AN INCIDENCE RATE OF (B)(4) FOR THE FACILITY WITH THESE (B)(4) REPORTED CASES. THIS EVENT APPEARS TO BE WITHIN RANGE OF EXPECTED ADVERSE EVENTS OF THIS TYPE ACCORDING TO THE EPTFE GRAFT LITERATURE. THEREFORE, A CAPA IS NOT WARRANTED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBERS FOR THE HERO ARTERIAL GRAFTS ASSOCIATED WITH THESE EVENTS ARE UNKNOWN. A REVIEW OF THE SHIPPING RECORDS INDICATED FOUR POSSIBLE LOT NUMBERS THAT WERE PROVIDED TO THE HOSPITAL IN THE THREE MONTH PERIOD PRIOR TO THE REPORTED EVENTS. QUALITY REVIEWED THE DEVICE HISTORY RECORDS FOR THESE LOTS AND CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL PHYSICAL, MICROBIAL, AND CHEMICAL SPECIFICATIONS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SURGEON STATED THAT THE ARTERIAL GRAFT WOULD NOT INCORPORATE EVEN AFTER 30 DAYS. THE EVENT WAS NOTICED DURING OPEN DECLOT OF THE ACTUAL GRAFT. THE SURGEON SWITCHED FROM USING A GORE VECTRA TUNNELER TO A KELLY-WICKE TUNNELER TO SEE IF THIS WAS A CAUSE OF TRAUMA TO THE PATIENT. HOWEVER, ISSUES STILL AROSE AFTER THE FACT. THE GRAFT WAS EXCISED JUST PAST THE CONNECTOR AND REPLACED WITH A VECTRA GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12318 HERO GRAFT VASCULAR GRAFT - PROSTHESIS DSY HEMOSPHERE, INC. HERO 1002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other