BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELWEAVE

    MDR report key: 1380693 · Received May 12, 2009

    Report

    Report Number
    9612515-2009-00006
    Event Type
    Death
    Date Received
    May 12, 2009
    Date of Event
    April 7, 2009
    Report Date
    May 12, 2009
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - QC AND MANUFACTURING RECORDS WERE REVIEWED. THE INSTRUCTIONS FOR USE WERE REVIEWED. A DEVICE FROM THE SAME LOT NO. 83085 WAS EVALUATED. RESULTS - THERE WERE 3 GRAFTS IN BATCH, THESE WERE 26MM DIAMETER GELWEAVE WITH A COLLAR AND RADIOPAQUE MARKERS AND WERE MANUFACTURED IN SEPTEMBER 2007. TWO GRAFTS WERE DISPATCHED TO USA BETWEEN SEPTEMBER AND NOVEMBER 2007. THERE WERE 4 GRAFTS IN BATCH, THESE WERE 20MM DIAMETER TRIFUCATE ARCH GRAFTS AND WERE MANUFACTURED IN 2008. ALL THE GRAFTS WERE DISPATCHED BETWEEN OCTOBER AND APPROX SEVEN MONTHS LATER. THERE WERE 6 GRAFTS, THESE WERE 24MM DIAMETER GELWEAVE WITH ANTE-FLO OFF SET BRANCH AND WERE MANUFACTURED IN JUNE 2008. ALL THE GRAFTS WERE DISPATCHED BETWEEN 2008 AND 2009. THERE WERE 4 GRAFTS, THESE WERE 30MM DIAMETER GELWEAVE STRAIGHT AND WERE MANUFACTURED IN AUGUST 2007. ALL GRAFTS WERE DISPATCHED IN 2007. 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 ALL BATCHES. GELATIN SEALING IS DESIGNED TO HYDROLYSE OVER A 14 DAY PERIOD AFTER IMPLANT. TISSUE IN-GROWTH OCCURS DURING THE HYDROLYSING PROCESS TO MAINTAIN A BLOOD SEAL. VASCUTEK'S IFU STATES AT CAUTION 11, "CAUTION SHOULD BE EXERCISED WHEN PERFORMING THE ELEPHANT TRUNK PROCEDURE. ALTHOUGH THERE HAS BEEN SUCCESS WITH THIS PROCEDURE, THERE HAVE BEEN A FEW REPORTS OF BLEEDING FROM THE IMPLANTED GRAFT DURING THE SECOND STAGE. VARIABILITY OF THE PTS HEALING RESPONSE MAY ACCOUNT FOR THIS DIFFERENCE". A DEVICE FROM THE SAME LOT AS 83085, WAS EVALUATED. GELATIN AND GLYCEROL CONTENT WAS TESTED. GELATIN CONTENT WAS WITHIN THE EXPECTED RANGE OF 15-20% WT. GLYCEROL CONTENT WAS GREATER THAN THE EXPECTED VALUE OF > 60% WT. BLOOD TESTING WAS CARRIED OUT ON THE RETURNED GRAFT. BLOOD TEST RESULTS PASSED VASCUTEK'S ACCEPTANCE CRITERIA. TEXTILE ANALYSIS SHOWED THAT THE GRAFTS OVERALL STRUCTURE WAS UNIFORM AND DID NOT POSSESS ANY ABNORMALITIES. SCANNING ELECTRON MICROSCOPIC IMAGES SHOWED NO DEFECTS IN THE TEXTILE STRUCTURE. CONCLUSIONS - VASCUTEK HAS PREVIOUSLY STATED CAUTION 11 IN THE IFU, THAT BLEEDING CAN OCCUR DURING THE SECOND STAGE, AND THE PT'S HEALING RESPONSE MAY ACCOUNT FOR THE VARIABILITY. DR HAS SINCE IMPLANTED A FURTHER 5 OF THESE DEVICES, NO ADVERSE EVENTS HAVE BEEN REPORTED FOR THESE SUBSEQUENT PROCEDURES. VASCUTEK HAS CONCLUDED THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE FAILURE.

    Description of Event or Problem · 1

    THE EVENT OCCURRED. DR CARRIED OUT AN ELEPHANT TRUNK OPERATION VASCULAR REPLACEMENT. THE ELEPHANT'S TRUNK PROCEDURE VASCULAR REPLACEMENT, IS A TECHNIQUE WHEREBY, EXCESS TUBULAR GRAFT MATERIAL IS INSERTED DURING ASCENDING AORTIC AND ARCH REPAIR TO FACILITATE THE SUBSEQUENT TREATMENT OF DISTAL AORTIC ANEURYSMS. THE FIRST STAGE WAS CARRIED OUT, AND THE SECOND STAGE WAS CARRIED OUT THREE DAYS LATER 2009. FOR THE FIRST STAGE, TWO GRAFTS WERE IMPLANTED, A 26MM DIAMETER GELWEAVE WITH A COLAR AND RADIOPAQUE MARKERS BEING USED FOR THE ELEPHANT'S TRUNK AND A 20MM DIAMETER GELWEAVE TRIFURCATE ARCH GRAFT. DURING THE SECOND STAGE, ANOTHER TWO GRAFTS WERE ALSO IMPLANTED, A 24MM DIAMETER GELWEAVE WITH ANTE-FLO OFF SET BRANCH AND A 30MM DIAMETER GELWEAVE STRAIGHT GRAFT. DURING THE SECOND STAGE, BLEEDING WAS OBSERVED IN THE TRUNK OF THE 26MM DIAMETER GELWEAVE GRAFT. VASCUTEK GRAFTS ARE MADE BLOOD TIGHT BY IMPREGNATION WITH GELATIN. THIS GELATIN HYDROLYSES OVER A 14 DAY PERIOD AFTER IMPLANTATION. THE GRAFT IS SUBSEQUENTLY SEALED WITH THE PT'S HEALING RESPONSE. VASCUTEK CAUTIONS IN ITS IFU THAT BLEEDING CAN OCCUR AT THE SECOND STAGE, IF THE PT HAS A POOR HEALING RESPONSE. THE PT DIED AFTER SEVERAL HOURS OF SURGERY. THE CAUSE OF DEATH IS UNK AT THIS POINT IN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE VASCULAR PROSTHESIS DSY VASCUTEK LTD. UNK 83085 0492

    Patients

    Seq Age Sex Outcome Treatment
    1 Death