BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELWEAVE STRAIGHT GRAFT

    MDR report key: 2696490 · Received August 10, 2012

    Report

    Report Number
    9612515-2012-00016
    Event Type
    Injury
    Date Received
    August 10, 2012
    Report Date
    August 7, 2012
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: IT IS UNKNOWN IF THE DEVICE WILL BE MADE AVAILABLE FOR INSPECTION AND EVALUATION. VASCUTEK LTD IS STILL AWAITING INFORMATION THAT RELATES TO THE INCIDENT. RESULTS: AS NO PRODUCT INFORMATION (LOT NO. OR S/N) HAS BEEN RETURNED TO VASCUTEK, A REVIEW OF THE ASSOCIATED MANUFACTURING RECORDS COULD NOT BE COMPLETED. OF NOTE: CLINICAL PAPERS PROVIDE EVIDENCE OF ROUTINE OCCURRENCE OF CARDIAC TAMPONADE OF 3.3%, 0.6% AND 8.0% OCCURRING AFTER VALVE REPLACEMENT SURGERIES. VASCUTEK HAS PERFORMED A REVIEW OF SIMILAR INSTANCES THAT INVOLVED THE GELWEAVE FAMILY OF PRODUCTS. (B)(4). CONCLUSIONS: (NO CONCLUSIONS CAN BE DRAWN). VASCUTEK DOES NOT HAVE ENOUGH INFORMATION OR THE PRODUCT TO DETERMINE THE ROOT CAUSE OF THE REPORTED DEFECT AT THIS TIME. ONCE THE FINALIZED COMPLAINT INFORMATION HAS BEEN RETURNED TO VASCUTEK LTD FOR EVALUATION; A FOLLOW-UP / FINAL INCIDENT REPORT WILL BE GENERATED DETAILING OUR INVESTIGATION FINDINGS. IT IS NOT KNOWN IF THE VASCUTEK GRAFT WAS USED IN CONJUNCTION WITH ANY OTHER DEVICE AT THIS TIME. THE GELWEAVE GRAFT WAS FIRST APPROVED IN EUROPE IN 1995, AND IN THE USA IN 1995 (K952293).

    Description of Event or Problem · 1

    VASCUTEK LTD, WAS MADE AWARE OF AN INCIDENT, THAT OCCURRED WITH A PATIENT WHO HAD A VASCUTEK MANUFACTURED, GELWEAVE, STRAIGHT, VASCULAR PROSTHESIS IMPLANTED. THIS EVENT IS 1 OF 12 SIMILAR EVENTS THAT HAVE BEEN REPORTED TO VASCUTEK LTD. FROM THE SAME CLINIC. VASCUTEK LTD WAS ADVISED OF THE INCIDENT ON THE (B)(6) 2012, VIA OUR (B)(4) DISTRIBUTOR . THE EVENT WAS DESCRIBED AS; THE PATIENT DEVELOPED "LATE TAMPONADES: (CARDIAC TAMPONADE) WITHIN 3-8 WEEKS OF THE INITIAL SURGERY TAKING PLACE; WHICH RESULTED IN THE PATIENT UNDERGOING CORRECTIVE SURGERY TO CLEAN THE DEVICE (GELWEAVE, STRAIGHT, VASCULAR PROSTHESIS) AND THEN APPLY BIO-GLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE STRAIGHT GRAFT VASCULAR PROSTHESIS DSY VASCUTEK LTD. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other