BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELWEAVE SIENA COLLARED 4 BRANCH PLEXUS RADIOPAQUE MARKERS

    MDR report key: 1501501 · Received October 8, 2009

    Report

    Report Number
    9612515-2009-00009
    Event Type
    Other
    Date Received
    October 8, 2009
    Date of Event
    June 16, 2009
    Report Date
    October 6, 2009
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: QC AND MANUFACTURING RECORDS WERE REVIEWED. AN OFF-CUT OF THE GRAFT HAS BEEN RETURNED TO VASCUTEK FOR ANALYSIS. RESULTS CODE: THERE WERE TOTAL OF THREE 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 HAVE BEEN REVIEWED AND THERE IS NOTHING TO SUGGEST ANY PROBLEMS. THE LEAK TEST RESULTS WERE WITHIN OUR SPECIFIED QUALITY CONTROL LIMITS FOR THIS PRODUCT. ALL WERE DISTRIBUTED IN OCTOBER 2007. NO OTHER REPORTS HAVE BEEN RECEIVED FOR THE OTHER TWO UNITS. ANALYSIS OF THE GRAFT IS TO TAKE PLACE. CONCLUSION CODE: NO CONCLUSION CAN BE IDENTIFIED AT THIS TIME.

    Description of Event or Problem · 1

    THE GELWEAVE SIENA COLLARED 4 BRANCH PLEXUS WITH RADIOPAQUE MARKERS IS CE MARKED. THE EVENT OCCURRED IN A HOSPITAL IN (B)(6). THE EVENT IS BEING REPORTED DUE TO PROLONGATION OF THE OPERATION. THE PATIENT ALSO HAD A POST OPERATIVE BRAIN SCAN. THERE WERE TWO AREAS OF CEREBRAL HEMORRHAGE. THE PATIENT UNDERWENT A SURGICAL ARCH REPLACEMENT. AFTER HEPARIN REVERSAL, THERE WAS BLOOD LEAKAGE FROM THE PROSTHESIS, WHICH RESULTED IN PROLONGATION. THE PATIENT RECEIVED BLOOD REPLACEMENT, PLATELETS, RED BLOOD CELLS AND FRESH FROZEN PLASMA. THE PATIENT'S COAGULATION FUNCTION DETERIORATED, REQUIRING ADDITIONAL PLATELETS, FRESH FROZEN PLASMA AND LOCAL ADMINISTRATION OF CELOX, WHICH CONTROLS ARTERIAL BLEEDING. THE CAUSE OF THE CEREBRAL HEMORRHAGE IS NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE SIENA COLLARED 4 BRANCH PLEXUS RADIOPAQUE MARKERS VASCULAR PROSTHESIS DSY VASCUTEK LTD. UNK 82648 0465

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention