BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELWEAVE STRAIGHT GRAFT

    MDR report key: 2696487 · Received August 10, 2012

    Report

    Report Number
    9612515-2012-00009
    Event Type
    Injury
    Date Received
    August 10, 2012
    Date of Event
    April 16, 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: NO GRAFT IS AVAILABLE FOR INSPECTION AND EVAL AS THE DEVICE HAS NOT BEEN EXPLANTED; THEREFORE NO TESTING OF THE DEVICE CAN TAKE PLACE. RESULTS: AS NO PRODUCT WAS AVAILABLE FOR INSPECTION AND EVAL A REVIEW OF THE MFG RECORDS ASSOCIATED WITH THE AFFECTED PRODUCT (GELWEAVE STRAIGHT VASCULAR PROSTHESIS LOT NO. 128042/1, S/N (B)(4)) WAS UNDERTAKEN; THIS CONFIRMED THAT THE PRODUCT WAS MFG WITHIN SPECIFICATIONS. (B)(4). VASCUTEK PERFORMED A REVIEW OF SIMILAR INSTANCES THAT INVOLVED THE GELWEAVE FAMILY OF PRODUCTS. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN, THE ROOT CAUSE OF THE REPORTED DEFECT COULD NOT BE ESTABLISHED. ADDITIONAL INFO WILL BE REQUESTED FROM THE SURGEON TO IDENTIFY HOW THE SURGICAL PROCEDURE LED TO CARDIAC TAMPONADE. THE GELWEAVE GRAFT WAS FIRST APPROVED IN (B)(4) 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 PT WHO HAD A VASCUTEK MFG, GELWEAVE, STRAIGHT, VASCULAR PROSTHESIS IMPLANTED IN CONJUNCTION WITH A MASTERS SERIES, ROTATABLE, AORTIC HEART VALVE. THIS EVENT IS 1 OF 12 SIMILAR EVENTS THAT HAVE BEEN REPORTED TO VASCUTEK LTD. FROM THE SAME CLINIC. VASCUTEK HAS BEEN MADE AWARE OF AN INCIDENT THAT INVOLVED A VASCUTEK MFG, GELWEAVE, STRAIGHT, VASCULAR PROSTHESIS (LOT NO. 128042/1, S/N (B)(4)). THE DEVICE WAS ORIGINALLY IMPLANTED ON THE (B)(6) 2012. ON THE (B)(6) 2012, THE PT UNDERWENT AN ELECTIVE SURGICAL PROCEDURE DUE TO SERIOUS AORTIC STENOSIS AND AN ASCENDING AORTIC ANEURYSM; THE PT PRESENTED WITH A LOW CARDIAC OUTPUT. THE SURGEON IDENTIFIED A (CARDIAC) TAMPONADE. THE SURGEON THEN RE-OPERATED; THE BUILD UP OF BLOOD (TAMPONADE) WAS DRAINED VIA A CANNULA. ON THE (B)(6) 2012, THE PT WAS STABLE AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE STRAIGHT GRAFT VASCULAR PROSTHESIS DSY VASCUTEK LTD. NA 128042/1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other