BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELWEAVE STRAIGHT

    MDR report key: 2214216 · Received July 27, 2011

    Report

    Report Number
    9612515-2011-00004
    Event Type
    Other
    Date Received
    July 27, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 26, 2011
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MANUFACTURING AND QC RECORDS REVIEWED. GRAFT WAS EXPLANTED AND DISPOSED OF BY THE HOSPITAL. RESULTS: THERE WERE A TOTAL OF 73 UNITS IN THE BATCH. ALL GRAFTS WERE GELATIN SEALED. AFTER SEALING, 100% OF ALL GRAFTS ARE WHOLE GRAFT POROSITY TESTED. THIS INVOLVES PRESSURIZING THE DEVICE WITH AN ISOPROPANOL ALCOHOL/GLYCEROL MIXTURE AND MEASURING THE FLOW RATE. THE MAXIMUM PERMISSIBLE FLOW RATE WAS DETERMINED BY COMPARISON WITH CITRATED COWS BLOOD. THE QUALITY CONTROL AND MANUFACTURING RECORDS WERE REVIEWED AND THERE WAS NOTHING TO SUGGEST ANY PROBLEMS. THE LEAK TEST RESULTS WERE WITHIN OUR SPECIFIED QUALITY CONTROL LIMIT FOR THIS PRODUCT. ALL GRAFTS WERE DISTRIBUTED BETWEEN MARCH AND MAY 2011. THE USAGE RATE OF THIS PARTICULAR MODEL OF GRAFT IS SUCH THAT IT MAY BE ASSUMED THE MAJORITY HAVE NOW BEEN IMPLANTED. NO OTHER REPORTS HAVE BEEN RECEIVED FOR THE OTHER UNITS. 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 THE (B)(6) HOSPITAL IN (B)(6) IN USA. NO DEATH OR SERIOUS INJURY TOOK PLACE. THE EVENT IS BEING REPORTED AS INTERVENTION WAS REQUIRED. A GELWEAVE GRAFT WAS USED AND DURING THE OPERATION AND THE DOCTOR OBSERVED A SERIOUS AMOUNT OF BLOOD LEAKAGE FROM THE GRAFT. ANOTHER GRAFT WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT RECOVERED WELL FROM THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE STRAIGHT VASCULAR PROSTHESIS DSY VASCUTEK LTD. GELWEAVE 123191/2 3434

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention