BEUDAMED
    FDA Adverse Event Other Summary report: N

    CQUR, EDGE, MESH

    MDR report key: 2963913 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00226
    Event Type
    Other
    Date Received
    January 2, 2013
    Date of Event
    April 2, 2012
    Report Date
    April 20, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K080691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE C-QUR EDGE EXPLANT WAS EXAMINED CLOSELY UPON RETURN. THE MESH WAS ATTACHED TO A PIECE OF GAUZE WITH A COUPLE OF METAL PINS. THE GAUZE WAS CAREFULLY REMOVED FROM THE MESH AND SET ASIDE. LITTLE COATING REMAINED ON THE RETURNED PIECE OF C-QUR EDGE. THERE WERE THREE TORN AREAS ON THE SAMPLE; ONE CIRCULAR AREA IN THE CENTER APPROXIMATELY 4 INCHES IN DIAMETER, A HALF CIRCLE ABOUT 3 INCHES IN DIAMETER THAT ENCOMPASSED BOTH THE REINFORCED EDGE AND SINGLE LAYER PORTION OF THE MESH AND APPROX A 3 INCH LONG SLIT IN THE SINGLE MESH LAYER PORTION OF THE DEVICE RUNNING ALONG THE REINFORCED EDGE. IT IS UNK IF THE TEARING OCCURRED IN-VIVO OR DURING REMOVAL OF THE MESH. DURING EXAMINATION OF THE SAMPLE, IT WAS NOTED THAT THE REINFORCED EDGE WAS INTACT AROUND THE ENTIRE PERIMETER OF THE C-QUR EDGE MESH. THERE WAS MINIMAL TISSUE INGROWTH ON THE ABDOMINAL WALL SIDE OF THE MESH. POST-OPERATIVE SEROMA FORMATION AFTER HERNIA REPAIR IS VERY COMMON. IT HAS BEEN REPORTED THAT APPROXIMATELY A THIRD OF HERNIA REPAIRS SHOW CLINICALLY EVIDENT SEROMA FORMATION AND AS MANY AS 100% OF CASES EXHIBIT SEROMAS WHEN EXAMINED BY ULTRASOUND. POST OPERATIVE INFECTION AFTER HERNIA REPAIR USING MESH IS ALSO A COMMON OCCURRENCE AND THE RATE OF INFECTION CAN BE INFLUENCED BY A VARIETY OF SURGICAL AND PT FACTORS. THE RATE OF INFECTION IS KNOWN TO BE INCREASED DURING OPEN HERNIA REPAIRS AND IN PATIENTS WHO ARE IMMUNOSUPPRESSED, SMOKERS, DIABETIC, AND/OR OBESE. SEE ATTACHED WHITE PAPER, "SURGICAL SITE INFECTION IN HERNIA REPAIR: AN EVIDENCE BASED ANALYSIS". THE LOT HISTORY AND STERILIZATION RECORDS OF THIS LOT OF MESH WERE EXAMINED AND NO DEVIATIONS WERE NOTED. ALSO, THE LOT HISTORY RECORD OF THE PROLITE ULTRA MESH USED TO MANUFACTURE THIS LOT OF C-QUR EDGE WAS REVIEWED AND THE MECHANICAL STRENGTH PROPERTIES (BALL BURST AND SUTURE RETENTION STRENGTH) WERE WITHIN SPECIFICATIONS. ADDITIONAL SAMPLES OF C-QUR EDGE MESH FROM THE SAME LOT WERE NOT AVAILABLE FROM ATRIUM INVENTORY FOR TESTING. A DEFINITIVE CAUSE OF THE SEROMA AND SUBSEQUENT INFECTION IN THIS CASE CANNOT BE DETERMINED FROM THE INFO PROVIDED; HOWEVER, THERE ARE NO REASONS TO CONCLUDE THAT THIS C-QUR EDGE MESH DEVICE ITSELF WAS THE ROOT CAUSE OF THE SEROMA OR INFECTION ASSOCIATED WITH THE RGA.

    Description of Event or Problem · 1

    EVENT DESCRIPTION. APPROX ONE YEAR LATER FROM THE IMPLANTATION OF THE RELEVANT C-QUR EDGE, IT WAS RECOGNIZED THAT THERE OCCURRED A SEROMA BETWEEN THE MESH AND PT'S SKIN AND THAT IT WAS GRADUALLY GROWING AND CAME OUT OF THE WOUND. A CHRONOLOGY OF EVENTS: ON (B)(6) 2011, THE RELEVANT C-QUR WAS PLACED INTO THE ABDOMINAL CAVITY OF THE PT. ON (B)(6) 2011 THE PT WAS RELEASED FROM THE HOSPITAL. IN (B)(6) 2011, AT THE TIME OF VISIT THE PHYSICIAN JUDGED THAT THERE WAS NO PROBLEM WITH THE SYMPTOMS, WITH THE ECHO NOTING THAT A QUANTITY OF FLUIDS POOLED. THE CPR WAS 1.24 MG/DL. IT WAS CONFIRMED THE INFECTION WAS NOT TRANSMITTED. ON (B)(6), THE CRP WAS 0.47 MG/DL, AND IT WAS NOTED THAT THE FLUIDS CAME OUT OF THE WOUND AND THAT THE WOUND BEGAN TO RISE. ON (B)(6) 2012, IT WAS NOTED THE PT HAD NO FEVER. ON (B)(6) 2012, IT WAS NOTED THE PT HAD A FEVER OF 40 DEGREES C. THE ABDOMINAL LAVAGE WAS PERFORMED BY LAPAROTOMY. THE SUCCESSFUL TISSUES ENGRAFTMENT WAS NOTED TO BE UNDER THE MESH. THERE SEEMED TO BE NO FLUIDS UNDER THE MESH. IT WAS CONFIRMED THAT THE INFECTION WAS TRANSMITTED; THE (B)(6) AND PREVELLE BIVIA WERE IDENTIFIED AS THE INFECTIOUS ORGANISMS. ON (B)(6), THE PT WAS PRESCRIBED A COURSE OF ANTIBIOTICS OF MINOMYCIN (THE DOSAGE FORM IS UNK) AND ANOTHER DRUG (UNK). THE ADMINISTRATION OF THEIR ANTIBIOTICS WORKED WELL AND WAS ALLEVIATING LOCAL INFLAMMATION. HOWEVER, THE GAUZES TO BE USED WERE STILL STICKY. THE PHYSICIAN DECIDED ON COURSES OF TREATMENT, NOT REMOVING THE PLACED MESH FROM THE PT BUT LEAVING IT THERE; HE WOULD MONITOR THE PT, ADMINISTERING THE ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432 CQUR, EDGE, MESH FTL ATRIUM MEDICAL CORP. 31236 10641408

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention