BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR EDGE MESH

    MDR report key: 2963645 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00128
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    February 1, 2010
    Report Date
    February 1, 2010
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010 ATRIUM RECEIVED A PHOTOGRAPH OF THE EXPLANT VIA E-MAIL, BUT THE EXPLANT WAS NOT RETURNED TO ATRIUM FOR GROSS OR HISTOLOGIC EXAMINATION. UPON EXAMINATION OF THE EXPLANT PHOTOGRAPH, IT IS APPARENT THAT THE MESH IS FOLDED AND BUNCHED UP. THERE APPEARS TO BE SOME TISSUE INGROWTH IN AND AROUND THE FOLDS IN THE MESH. THE COMPLAINT OF "EXTREME SHRINKAGE OF THE MESH" IS MOST LIKELY RELATED TO THE FOLDING OF THE MESH. THE MESH FOLDING COULD BE THE RESULT OF INADEQUATE TENSION PLACED ON THE MESH DURING IMPLANTATION OR A FAILURE OF THE FIXATION USED TO HOLD THE MESH TAUGHT AGAINST THE ABDOMINAL WALL. THE OBSERVATION NOTED BY THE SURGEON THAT THE STAY-SUTURES HAD BEEN TORN OUT SUGGESTS A FAILURE IN THE FIXATION OF THE MESH TO THE ABDOMINAL WALL. IT IS IMPOSSIBLE TO TELL FROM THE PHOTOGRAPH WHERE THE SUTURES WERE LOCATED OR HOW THE SUTURE FIXATION FAILED. COMPLICATING THIS FIXATION WAS THE SIMULTANEOUS IMPLANTATION OF A PIECE OF PROCEED MESH. OVERLAPPING AND IMPLANTING TWO DIFFERENT MESHES WITH VISCERAL SIDES DESIGNED TO REDUCE TISSUE INGROWTH CERTAINLY PLAYED A ROLE IN THIS RECURRENCE. ADEQUATE TISSUE INGROWTH INTO THE POSTERIORLY PLACED MESH WOULD BE VERY DIFFICULT IF NOT IMPOSSIBLE TO OBTAIN REQUIRING SUBSTANTIAL PERMANENT FIXATION. THE LOT HISTORY OF THE MESH WAS REVIEWED AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS. PROPER FIXATION IS CRITICAL IN THE REPAIR OF LARGE VENTRAL HERNIAS IN OBESE PTS AND OUR EXAMINATION OF THE CASE HISTORY AND EXPLANT INDICATE THE POTENTIAL FOR LESS THAN ADEQUATE FIXATION LEADING TO FAILURE OF THE REPAIR.

    Description of Event or Problem · 1

    C-QUR MESH EXPLANTED AFTER 1 YEAR. DOCTOR CLAIMS IT HAS SHRUNK IN SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645 C-QUR EDGE MESH FTL ATRIUM MEDICAL CORP. 31237 104462650

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROCEED