BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 2857471 · Received November 16, 2012

    Report

    Report Number
    2530154-2012-00016
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 16, 2012
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD CODE: LOT HISTORY RECORDS REVIEWED. RESULTS: NO DEVIATIONS WERE FOUND DURING LOT HISTORY RECORDS REVIEW THAT WOULD BE EXPECTED TO CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. RESULTS CODE: EXTREME ABDOMINAL PRESSURE LIKELY CONTRIBUTED TO DEVICE TEARING. COMPLAINT NARRATIVE: THE PT COUGHED AND FELT A POP IN HER ABDOMEN. EXPLORATORY LAPAROTOMY TODAY PRESENTED WITH XCM HAVING A TEAR. REVIEW OF DEVICE HISTORY RECORDS: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR KNC PART NUMBER 30010-22, LOT NUMBER 99930. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES NOTED WITHIN THE MFG OPERATIONS RELATING TO THE REPORTED FAILURE MODE. THE DEVICE LOT MET ALL PRE-DETERMINED ACCEPTANCE CRITERIA. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE CAN BE ASSIGNED. IT APPEARS AS THOUGH THE TEAR WAS PRECIPITATED BY EXTREME PRESSURE, PERHAPS BY BEING PLACED UNDER TENSION. IT IS ALSO UNCLEAR IF THE SUTURE NOTED WAS A "REPAIR" TO A PREVIOUS TEAR BY THE PHYSICIAN DURING IMPLANT. ACTIONS: KNC WILL CONTINUE TO TREND FOR LIKE-RE-OCCURRENCES AND TAKE APPROPRIATE ACTIONS AS WARRANTED.

    Description of Event or Problem · 1

    XCM BIOLOGIC WAS IMPLANTED IN AN OBESE PT TO BRIDGE AN ABDOMINAL WALL AS PART OF A VENTRAL HERNIA REPAIR PROCEDURE. IT WAS REPORTED THAT THE PT HAD BEEN COUGHING POST-OPERATIVELY AND ON DAY 7 POST-OPERATIVE SHE REHERNIATED. DURING REVISION SURGERY, THE MESH THE SURGEON NOTED THAT THE MESH HAD A PULLED AWAY FROM THE SUTURE LINE ON ONE SIDE AND THERE WAS AN APPROX 10CM TEAR IN THE BODY OF THE MESH. THE XCM BIOLOGIC MESH WAS REMOVED AND A SYNTHETIC MESH WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCM BIOLOGIC TISSUE MATRIX BIOLOGIC SURGICAL MESH FTM KENSEY NASH CORP. 30010-22 99930

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention PROLENE SUTURE