BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT

    MDR report key: 2665451 · Received July 19, 2012

    Report

    Report Number
    1835959-2012-00010
    Event Type
    Injury
    Date Received
    July 19, 2012
    Date of Event
    June 19, 2012
    Report Date
    July 19, 2012
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K062696
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EC METHOD DESC-1 - NO DEVICE EVALUATED. DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE DEVICE WAS SECURED IN PLACE BY THE USE OF METAL TACKS. THESE METAL TACKS MAY HAVE CONTRIBUTED TO THE INFLAMMATORY RESPONSE AND ADHESION FORMATION FOUND UPON REOPERATION WHICH HAD CAUSED THE PT'S SYMPTOMS OF VOMITING AND DYSPHAGIA. THE ARTICLE "COMPARISON OF ADHESION FORMATION ASSOCIATED WITH PRO-TACK (US SURGICAL) VERSUS A NEW MESH FIXATION DEVICE, SALUTE (ONUX MEDICAL) SHOWS ADHESION FORMATION REGARDLESS OF TACK TYPE. ADDITIONALLY, A CONSULTING SURGEON INDICATED THE POTENTIAL COMPLICATIONS OF METAL TACKS COULD BE OF ISSUE IN THIS CASE. IN ADDITION, THE SURGEON USED A 4-LAYER TISSUE GRAFT INSTEAD OF THE DEVICE SPECIFICALLY MARKETED FOR HIATAL HERNIA REPAIR WHICH HAS A PRE-CUT U SHAPE IN THE DEVICE. DETAILS REGARDING WHETHER DR. (B)(6) CUT THE GRAFT AND IF SO TO WHAT SIZE OR WHETHER THE GRAFT WAS USED AS REINFORCEMENT OVER THE CLOSURE ARE UNKNOWN AT THIS TIME. ACUTE OR CHRONIC INFLAMMATION IS LISTED AS A POTENTIAL COMPLICATION IN THE IFU. ADDITIONAL INFORMATION: LEBLANC, K.A., STOUT, R.W., KEARNEY, M.T., PAULSON, D.B. COMPARISON OF ADHESION FORMATION ASSOCIATED WITH PRO-TACK (US SURGICAL) VS A NEW MESH FIXATION DEVICE, SALUTE (ONUX MEDICAL). SURG. ENDOSC (2003) 17: 1409-1417.

    Description of Event or Problem · 1

    FIVE WEEKS AFTER HIATAL HERNIA REPAIR WITH PLACEMENT OF THE BIODESIGN 4-LAYER TISSUE GRAFT, THE PT WAS COMPLAINING OF DIFFICULTY SWALLOWING AND WAS EVENTUALLY UNABLE TO SWALLOW OR EAT WITHOUT VOMITING. DR. (B)(6) REOPERATED ON THE PT AND FOUND AN INFLAMMATORY RESPONSE AND THAT THE STOMACH WAS ADHERED TO THE DIAPHRAGM. CURRENT PT STATUS WAS NOT PROVIDED BY REPORTER. DR. (B)(6) USED METAL TACKS TO SECURE THE GRAFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT SURGISIS ES FTM COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L