BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELSOFT

    MDR report key: 2170147 · Received June 29, 2011

    Report

    Report Number
    9612515-2011-00003
    Event Type
    Other
    Date Received
    June 29, 2011
    Date of Event
    December 16, 2010
    Report Date
    June 29, 2011
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE GRAFT WAS RECEIVED BY VASCUTEK IN (B)(4) 2011. NO ADVERSE EVENT DETAILS WERE RECEIVED UNTIL (B)(4) 2011, WHEN A DEVICE RELATIONSHIP COULD BE ESTABLISHED. PHOTOGRAPHS OF THE DAMAGED GRAFT CLEARLY SHOWS 6 AREAS WHERE THE STENT GRAFT HAS WORN THROUGH THE POLYESTER FABRIC. AN AREA WHERE THE ALLEGED DETERIORATION OF THE GELSOFT GRAFT ORIGINALLY OCCURRED CANNOT BE IDENTIFIED. THIS TYPE OF EVENT IS VERY RARE IN VASCUTEK'S EXPERIENCE. (B)(4). THE CLINICAL PAPER BY NUNN (1) DESCRIBES INTRINSIC DACRON GRAFT FAILURE. THE PAPER INDICATES THAT THE INTRINSIC GRAFT FAILURE OCCURS IN (B)(4) OF PTS. MFG AND QC RECORDS WERE UNABLE TO BE REVIEWED DUE TO NO BATCH DETAILS AVAILABLE. (B)(4). RESULTS: NO BATCH DETAILS WERE AVAILABLE, THEREFORE, NO BATCH RECORDS COULD BE REVIEWED. CONCLUSION: VASCUTEK WILL RESPOND TO THE SURGEON AND PROVIDE DETAILS OF HIS RESPONSE IN OUR FINAL REPORT.

    Description of Event or Problem · 1

    THIS EVENT IS BEING REPORTED FOR A GELSOFT GRAFT. THE EVENT OCCURRED IN FRANCE. THE EVENT IS BEING REPORTED AS INTERVENTION WAS REQUIRED TO TREAT DETERIORATION OF A GELSOFT GRAFT, WHICH WAS IMPLANTED IN 1992 OR 1995, EXACT DETAILS ARE NOT AVAILABLE. VASCUTEK WAS AWARE THAT AN EVENT TOOK PLACE WHEN IT WAS ORIGINALLY REPORTED ON (B)(4) 2011. HOWEVER, ACTUAL DETAILS OF THE EVENT WERE RECEIVED ON (B)(4) 2011. VASCUTEK HAD TRIED ON NUMEROUS OCCASIONS TO GET DETAILS, BUT THE DOCTOR DID NOT RESPOND. IN 1992 OR 1995, A VASCUTEK GELSOFT GRAFT WAS IMPLANTED. ON (B)(6) 2010, A (B)(4) GELSOFT PLUS GRAFT WAS IMPLANTED FOR A FALSE ANEURYSM AT THE RIGHT SIDE OF THE GRAFT. ALSO ON (B)(6) 2010, A STENT FLUENCY (8MM DIA X 40MM LONG) WAS DEPLOYED TO TREAT A DETERIORATION OF THE ORIGINAL PROSTHETIC GRAFT (IMPLANTED IN 1992 OR 1995). THEN ON (B)(6) 2010, THE GELSOFT/GELSOFT PLUS/STENT FLUENCY COMBINATION WAS EXPLANTED DUE TO FORMATION OF A PERIPROSTHETIC SEROMA. A GORETEX EPTFE BYPASS GRAFT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELSOFT VASCULAR PROSTHESIS DSY VASCUTEK LTD. NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention