BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELWEAVE WITH SIDE BRANCH (ANTE-FLO)

    MDR report key: 1914496 · Received November 25, 2010

    Report

    Report Number
    9612515-2010-00010
    Event Type
    Other
    Date Received
    November 25, 2010
    Date of Event
    October 17, 2010
    Report Date
    November 25, 2010
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MFG AND QC RECORDS REVIEWED. RESULTS: THERE WERE A TOTAL OF 4 UNITS IN THE BATCH. THE QUALITY CONTROL AND MFG RECORDS WERE REVIEWED AND THERE WAS NOTHING TO SUGGEST ANY PROBLEMS. ALL GRAFTS WERE GELATIN SEALED. AFTER SEALING, 100% OF ALL GRAFTS ARE LEAK TESTED. THE LEAK TEST RESULTS WERE WITHIN OUR SPECIFIED QUALITY CONTROL LIMIT FOR THIS PRODUCT. ALL GRAFTS WERE DISTRIBUTED IN APRIL 2008. THE USAGE RATE OF THIS PARTICULAR MODEL OF GRAFT HAVE NOW BEEN IMPLANTED. NO OTHER REPORTS HAVE BEEN REC'D FOR THE OTHER UNITS. CONCLUSIONS: VASCUTEK WILL RESPOND TO THE SURGEON AND PROVIDE DETAILS OF OUR INVESTIGATION IN OUR FINAL REPORT.

    Description of Event or Problem · 1

    THE EVENT OCCURRED AT (B)(6) IN (B)(6). THE EVENT IS BEING REPORTED DUE TO INTERVENTION BEING REQUIRED TO EXPLANT THE GRAFT. THE DOCTOR CONDUCTED AN EMERGENCY OPERATION TO REPLACE A LARGE BLOOD VESSEL IN THE PT WITH A GELWEAVE BRANCH GRAFT. DURING THE OPERATION THE DOCTOR OBSERVED CONTINUOUS BLEEDING FROM THE GRAFT AND THEREFORE HE DECIDED TO REPLACE THE GRAFT WITH ANOTHER GELWEAVE GRAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PT RECOVERED WELL FROM THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE WITH SIDE BRANCH (ANTE-FLO) VASCULAR PROSTHESIS DSY VASCUTEK LTD. GELWEAVE 88626 0768

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention