BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 2460886 · Received February 13, 2012

    Report

    Report Number
    2530154-2012-00002
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 12, 2012
    Report Date
    February 13, 2012
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: PHOTOGRAPHS TAKEN BY THE SURGEON ON THE DATE OF EXPLANT WERE REVIEWED. LOT HISTORY RECORDS REVIEWED. RESULTS: GENERAL SURGEON REVIEWER'S EVAL: IT IS NOT CLEAR WHETHER THE PT'S ABDOMEN WAS LEFT OPEN INTENTIONALLY OR THERE WAS A HERNIA PRE-OPERATIVELY. IF THERE WAS AN OPEN WOUND, BACTERIA WOULD HAVE BEEN PRESENT, AND BEEN RESPONSIBLE FOR THE EARLY DEGRADATION OF THE GRAFT. MECHANICAL FACTORS, SUCH AS SUTURING TECHNIQUE AND TISSUE ISCHEMIA, MAY ALSO HAVE CONTRIBUTED TO POOR WOUND HEALING. IN FACT, WOUND EDGE ISCHEMIA OR INCOMPLETELY EXCISED SCAR CAN BE SEEN IN THE PHOTOGRAPHS. THE REASON FOR EARLY DEGRADATION MAY ALSO BE THE PT'S OWN PROTEASES THAT ARE ACTING NORMALLY FOR THE PT, OR HAVE BEEN "RAMPED UP" BY THE BACTERIA AND WOUND ISCHEMIA. THE LOCATION OF GRAFT PLACEMENT RELATIVE TO THE FASCIA IS ALSO UNCLEAR, AS IS THE USE OF SKIN FLAPS. IF THE GRAFT WAS PLACED ANTERIOR TO THE FASCIA, GRAFT EXPOSURE TO THE ATMOSPHERE COULD BE A FACTOR. IN ADDITION, THE GRAFT BEING SURROUNDED BY HEMATOMA, AND POSSIBLY LIFTED OFF THE UNDERLYING TISSUE WOULD INHIBIT INCORPORATION. ON ALL LIKELIHOOD, THE CAUSE OF GRAFT DEGRADATION IS MULTIFACTORIAL, INCLUDING A COMBINATION OF PT FACTORS AND SURGICAL TECHNIQUE. RESULTS: NO DEVIATIONS WERE FOUND DURING LOT HISTORY RECORDS REVIEW THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EARLY GRAFT DEGRADATION.

    Description of Event or Problem · 1

    THE PT IS A (B)(6), FEMALE, WITH A HISTORY OF SYSTEMIC LUPUS ERYTHEMATOSUS AND INTESTINAL INFECTION REQUIRING BOWEL RESECTION AND JEJUNOSTOMY. THEREAFTER, SHE WAS SUBJECTED TO "MECHANICAL SWEEPING AND WASHING" FOR INFECTION CONTROL. TWO MONTHS LATER, THE PT WAS OPERATED UPON TO CLOSE THE JEJUNOSTOMY AND THE ABDOMINAL WALL WAS REPAIRED WITH BIOLOGICAL MESH (XCM BIOLOGIC). SIX DAYS LATER, THE PT HAD EVIDENCE OF A WOUND HEMATOMA. THEREFORE, THE SURGEONS DECIDED TO OPEN THE WOUND IN ORDER TO DRAIN THE HEMATOMA. AT THAT TIME, THE SURGEONS NOTED THAT XCM WAS PARTIALLY DEGRADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCM BIOLOGIC TISSUE MATRIX BIOLOGIC SURGICAL MESH FTM KENSEY NASH CORP. 30012-25 92887

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention PDS1 SUTURE