BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 8828330 · Received July 25, 2019

    Report

    Report Number
    2210968-2019-84663
    Event Type
    Injury
    Date Received
    July 25, 2019
    Report Date
    July 2, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT INVOLVING THE MESH IS CAPTURED IN MW# 2210968-2019-84658. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ACTA CHIR BELG. 2010; 110: 376-382. DOI: HTTPS://DOI.ORG/10.1080/00015458.2010.11680639.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: THE ANTEROLATERAL THIGH FLAP FOR COMPLICATED ABDOMINAL WALL RECONSTRUCTION AFTER GIANT INCISIONAL HERNIA REPAIR. IN THE MANAGEMENT OF GIANT INCISIONAL HERNIAS WITH LOSS OF DOMAIN SEVERAL SURGICAL OBSTACLES HAVE TO BE ADDRESSED. ADEQUATE COVERAGE OF THE DEFECT USING MESH, SUFFICIENT LOCAL TISSUE ADVANCEMENT AND PREVENTION OF WOUND AND MESH INFECTIONS ARE PREREQUISITES FOR SUCCESS. THE AUTHORS PRESENTED A CASE OF A COMPLICATED GIANT INCISIONAL HERNIA REPAIR AFTER ONCOLOGIC SURGERY, IN WHICH WE CHOSE FOR AN INTRA-ABDOMINAL MESH REPAIR USING A COMPOSITE MESH. A (B)(6)-YEAR-OLD OBESE MAN HAD AN ABDOMINAL SURGERY FOR THE FIRST TIME IN 2004 DUE TO COLORECTAL MALIGNANCY. SIX MONTHS LATER, RECURRENCE OCCURRED AT THE SECTION PLANE OF THE FORMER LIVER RESECTION. A SECOND RESECTION WAS PROPOSED. DURING THIS TIME, THE AUTHORS USED INTRAPERITONEAL PROCEED MESH (ETHICON) PLACEMENT TO ENABLE COVERAGE OF PART OF THE MESH BY AUTOLOGOUS FASCIA. ALL MESHES WERE FIXED TOGETHER BY USING A KIND OF VEST-OVER-PANTS SUTURING METHOD WITH AN OVERLAP OF 5 CM BY NON-RESORBABLE 2/0 SUTURES. THE MESHES WERE FIXED TO THE ABDOMINAL WALL BY SLOWLY PDS 2-0 RESORBABLE RUNNING SUTURES (ETHICON). SIX DAYS POST-OPERATIVE, INITIAL SIGNS OF WOUND DEHISCENCE WERE OBVIOUS AND VACUUM ASSISTED CLOSURE WOUND MANAGEMENT WAS APPLIED OVER THE COMPLETE LENGTH OF THE INCISION. A MULTI-RESISTANT COAGULASE NEGATIVE STAPHYLOCOCCUS WAS CULTURED FROM THE WOUND AND TREATED WITH VANCOMYCIN. A SKIN DEFECT OF MORE THAN 200 CM REMAINED AND WAS TREATED WITH NEGATIVE PRESSURE THERAPY, FOLLOWED BY ANTEROLATERAL THIGH FLAP. COMPLICATIONS ASSOCIATED WITH GIANT INCISIONAL HERNIA REPAIR HAVE A WIDE CONTINUUM OF SEVERITY AND, IF NOT RECOGNIZED EARLY, MIGHT BE DEVASTATING. BECAUSE ABDOMINAL WALL RECONSTRUCTION OCCURS FOLLOWING MULTIPLE ABDOMINAL PROCEDURES, THE VASCULAR SUPPLY OF THE SURROUNDING SOFT TISSUE HAS BEEN INTERRUPTED AND CAN PREDISPOSE THE PATIENT TO WOUND AND MESH INFECTIONS, AND SKIN NECROSIS. THE EXTENSIVE DISSECTION OF THE SUBCUTANEOUS TISSUE THAT IS OFTEN NECESSARY IN THESE CASES, AGGRAVATES THIS ASPECT EVEN MORE. HOWEVER, WITH CURRENT MICROSURGICAL TECHNIQUES AND MEDICAL DEVICES, SUCH AS COMPOSITE MESHES AND NEGATIVE PRESSURE THERAPY, LOSS OF DOMAIN, MESH INFECTION AND MUSCULOCUTANEOUS DEFECTS ARE NO LONGER UNRESOLVABLE OBSTACLES IN THE REPAIR OF GIANT ABDOMINAL HERNIAS AND MESH REMOVAL IS CERTAINLY NO LONGER THE ONLY OPTION IN THESE CASES. FACING THESE GIANT DEFECTS, SOME ESSENTIAL KEY-POINTS SHOULD BE KEPT IN MIND AT ALL TIMES: ADEQUATE PRE-OPERATIVE ASSESSMENT IS ESSENTIAL (CT-SCAN), AN ADEQUATE MESH OVERLAP, E.G. BY THE USE OF COMPOSITE MESHES, IS MANDATORY, AND ADEQUATE FASCIAL CLOSURE, OR AT LEAST ADEQUATE SOFT TISSUE COVERAGE (MICROSURGICAL TECHNIQUES), IS A PREREQUISITE FOR AN OPTIMAL REPAIR. IN CASES OF WOUND DEHISCENCE OR INFECTION, AN AGGRESSIVE TREATMENT (E.G. NEGATIVE PRESSURE THERAPY) IS ADVOCATED, AS IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619480 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention