BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGISIS EXL HERNIA REPAIR GRAFT

    MDR report key: 912504 · Received September 13, 2007

    Report

    Report Number
    1835959-2007-00004
    Event Type
    Death
    Date Received
    September 13, 2007
    Date of Event
    January 1, 2007
    Report Date
    September 13, 2007
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTM
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE COULD NOT BE EVALUATED SINCE IT WAS NOT RETURNED TO THE MANUFACTURER. CONCLUSION: PT WAS SEVERELY COMPROMISED PRIOR TO RECEIVING GRAFT. THE MEDICAL CONDITION AND NUTRITIONAL STATUS OF THE PT LIKELY INHIBITED INGROWTH AND INCORPORATION OF GRAFT INTO LOCAL TISSUE. FAILURE OF THE GRAFT WAS PROBABLY CAUSED BY EXCESSIVE STRESSES DUE TO CONTINUOUS COUGHING COMBINED WITH A WEAKENED GRAFT DUE TO LACK OF INCORPORATION. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE PT WAS TAKEN TO THE OPERATING ROOM TO "TAKE DOWN" THE COLOSTOMY AND ANASTOMOSE IT TO THE REMAINING DISTAL COLON. DR ASSISTED ON THIS OPERATION. BECAUSE THIS WAS CONSIDERED A CONTAMINATED FIELD, THEY REPAIRED THE HERNIA USING COOK SURGISIS EXL MESH. POST OPERATIVELY THE PT HAD A LOT OF PULMONARY PROBLEMS WITH LUNG SECRETIONS AND COUGHING. IT BEGAN AS SHE AWAKED FROM ANESTHESIA AN BECAME PROGRESSIVELY WORSE. ON THE 3RD DAY, INTENSIVE PULMONARY TOILETRY WAS BEGUN WITH TRACHEAL SUCTION, BREATHING TREATMENTS, AMBULATION, RESPIRATORY THERAPY. CLINICALLY THE PT WAS NOT DOING WELL AND NOT EATING WELL. NO EVIDENCE OF WOUND INFECTION, BUT ON THE 6TH POSTOPERATIVE DAY, PART OF THE SKIN SEPARATED, EXPOSING SOME OF THE UNDERLYING MESH. THE DOCTORS LAID A PIECE OF "ADAPTIC" ON THE WOUND. DR SAID THAT THEY WERE CONCERNED THAT THERE MIGHT HAVE BEEN DECREASED CIRCULATION TO THE SKIN WHEN THEY CLOSED THE WOUND UNDER TENSION DURING THE PRIOR OPERATION. THE NEXT DAY WHEN THEY INSPECTED THE WOUND, THE SURGISIS MESH SEEMED TO HAVE SPLIT DOWN THE MIDDLE OF ITS ENTIRE LENGTH WITH BOWEL VISIBLE AND PRESENT IN THE WOUND. THE PT WAS TAKEN BACK TO THE OPERATING ROOM THAT DAY BY ANOTHER SURGEON, ONE OF DR. LEGARE'S PARTNERS. THERE WAS NO BOWEL LEAKAGE. THE MESH INDEED HAD TORN ITS ENTIRE LENGTH. THERE WAS SOME MINIMAL DELAMINATION OF THE LAYERS CENTRALLY. THE REST OF THE MESH WHERE SUTURED TO THE FASCIA WAS FIRMLY INTACT. THE SURGEON SUTURED THE EDGES OF THE TORN GRAFT TO ITSELF, PLACED A DRAIN AND CLOSED THE SKIN. THE PT NEVER AWAKENED FROM THE ANESTHESIA AND COULD NOT BE WEANED FROM THE RESPIRATOR. AFTER 4 DAYS, THE FAMILY FELT THAT SHE HAD "SUFFERED ENOUGH" AND THE AGGRESSIVE CARE WAS STOPPED AND THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISIS EXL HERNIA REPAIR GRAFT SURGICAL MESH 21CFR878.3300 (FTM) FTM COOK BIOTECH, INC. SURGISIS EXL LB311863

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death NONE UNK