BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELWEAVE

    MDR report key: 2011841 · Received February 25, 2011

    Report

    Report Number
    9612515-2011-00002
    Event Type
    Other
    Date Received
    February 25, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 24, 2011
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MFG AND QC RECORDS WERE UNABLE TO BE REVIEWED DUE TO NO BATCH DETAILS AVAILABLE. RESULTS: VASCUTEK WILL WAIT FOR INVESTIGATION RESULTS FROM (B)(6). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE EVENT OCCURRED AT (B)(6) IN (B)(6). NO DEATH OR SERIOUS INJURY TOOK PLACE. IN 2001 - THE PT WAS IMPLANTED WITH A GELWEAVE GRAFT BY BENTALL PROCEDURE (USING SJM ST JUDE MEDICAL MECHANICAL STANDARD VALVE). IN (B)(6) 2010 - THE DOCTORS FOUND A TEAR NEAR THE CUFF OF THE VALVE AND WAS OOZING BLOOD FOR A LONG PERIOD. THE DOCTOR PERFORMED REDO OPERATION AND FOUND A HOLE (2MM) ON THE GRAFT, THEY CLOSED THE HOLE BY SUTURING AND RETAINED A PART OF ANASTOMOSES PORTION OF GRAFT FOR INVESTIGATION AT (B)(6) IN (B)(6). THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PT RECOVERED WELL FROM THE OPERATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention