BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3162075 · Received May 31, 2013

    Report

    Report Number
    3003910212-2013-00012
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 6, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: S. OLMI, M. UCCELLI, G. CESANA, F. CICCARESE, D. CARRIER, G. CASTELLO, G. LEGNANI, SMALL BOWEL OBSTRUCTION CAUSED BY MESH MIGRATION. G CHIR VOL. 34, MARCH 2013.

    Description of Event or Problem · 1

    A REVIEW OF THE G CHIR (JOURNAL OF SURGERY), MARCH 2013 REVEALED A CASE REPORT ENTITLED, "SMALL BOWEL OBSTRUCTION CAUSED BY MESH MIGRATION." THIS REPORT DESCRIBES A 59 YEAR OLD MALE PATIENT PRESENTING AT THE ER WITH ABDOMINAL PAIN, VOMITING AND SUB-OCCLUSIVE EPISODES. THE PATIENT HAS A HISTORY OF TRAUMA WITH LAPAROTOMY, SPLENECTOMY, INCISIONAL HERNIA REPAIR VIA RIVES PROCEDURE, RECURRENT INCARCERATED INCISIONAL HERNIA WITH MESH REMOVAL AND LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH "GORE-TEX" MESH. THE PATIENT UNDERWENT A SUBSEQUENT LAPAROTOMY WITH BOWEL RESECTION IN WHICH IT WAS NOTED THAT THE "INTESTINAL COIL" WAS "INSEPARABLE FROM THE ABDOMINAL WALL." THE "GORE-TEX" MESH WAS OBSERVED AT THE OPENING OF THE BOWEL, INSIDE THE LUMEN OF THE SMALL INTESTINE FROM THE RESECTED SPECIMEN. THE AUTHORS NOTED "THAT SEVERAL FACTORS CAUSED THE COMPLICATION: MULTIPLE LAPAROTOMIES HAVE CREATED A FIBROTIC REACTION AND A CHRONIC INFLAMMATION IN THE ABDOMINAL WALL WHICH, TOGETHER WITH NON-ABSORBABLE TACKS, PROBABLY WITH POOR FIXATION, AND MESH MATERIAL, CAUSED ADHESIONS BETWEEN THE PROSTHESIS AND INTESTINES. OVER THE YEARS, BECAUSE OF THIS CHRONIC INFLAMMATORY REACTION AND PERHAPS OF A MICROPERFORATION CAUSED BY SPIRAL TACKS, THE ENTIRE PROSTHESIS MIGRATED INTO THE LUMEN, CAUSING THE OCCLUSIVE STATE." THE REMOVAL OF THE MESH WAS SUCCESSFUL AND AT 3 MONTHS POST-OP, THE PATIENT WAS IN GOOD CONDITION, WITH A WELL-ESTABLISHED WOUND, AND WITHOUT CLINICAL EVIDENCE OF INCISIONAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241424 UNKNOWN NONE FTL W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention