BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 17942257 · Received October 16, 2023

    Report

    Report Number
    2210968-2023-07810
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    January 1, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2023-07808, 2210968-2023-07809, 2210968-2023-07811 CITATION: THE AMERICAN SURGEON 2022, VOL. 0(0) 1¿9 DOI: 10.1177/00031348221114027.

    Description of Event or Problem · 0

    TITLE: THE USE OF INLAY BRIDGE OF THE POSTERIOR FASCIA AS ADJUVANTS TO A MODIFIED RIVES-STOPPA REPAIR FOR DIFFICULT ABDOMINAL WALL HERNIAS. A RETROSPECTIVE REVIEW WAS CONDUCTED LOOKING AT ALL THE OPEN ABDOMINAL WALL HERNIA REPAIRS BETWEEN 2014 AND 2020. THE COHORT OF PATIENTS WHO HAD A BRIDGE PLACED IN ADDITION TO THE TRADITIONAL OPEN MODIFIED RIVES-STOPPA REPAIR WERE USED FOR THIS STUDY. NINETEEN PATIENTS HAD A MESH INLAY BRIDGE PLACED IN ADDITION TO A MODIFIED RIVES-STOPPA REPAIR WITH A SUBLAY (RETRORECTUS) ULTRAPRO MESH. FOR THE INLAY MESH 13 SYMBOTEX COMPOSITE MESHES WERE PLACED AND 6 VICRYL MESHES USED. THE AVERAGE SURFACE AREA OF THE DEFECT WAS 358.1 CM^2. THE AVERAGE LENGTH OF HOSPITALIZATION WAS 8.8 DAYS WITH A RANGE OF 3-24 DAYS. DURING THE IMMEDIATE POSTOPERATIVE COURSE THERE WERE 6 MINOR COMPLICATIONS. DURING THE FOLLOW-UP PERIOD THERE WERE 2 RECURRENCES. A MODIFIED RIVES-STOPPA COMPONENT SEPARATION PROCEDURE WAS THE PRE-OPERATIVE PLAN FOR ALL THE PATIENTS. ONLY THE COHORT OF PATIENTS WHO NEEDED A BRIDGING MESH IN THE POSTERIOR FASCIA WERE USED FOR THIS STUDY. ALL OTHER PATIENTS WERE EXCLUDED, INCLUDING THOSE REQUIRING EMERGENT SURGERY. ALL OPERATIONS WERE CONDUCTED USING ONLY AN OPEN TECHNIQUE. HERE IS WHERE A DEFECT REMAINED IN THE POSTERIOR RECTUS SHEATH/ TRANSVERSALIS FASCIA. USING INTERRUPTED PROLENE SUTURE EITHER A SYMBOTEX (MEDTRONIC, DUBLIN, IRELAND) OR VICRYL MESH (ETHICON, RARITAN, NEW JERSEY, USA) WAS SECURED TO THE TISSUE USING A PARACHUTE TECHNIQUE FOR INTRAPERITONEAL PLACEMENT AND SUFFICIENT OVERLAP OF THE TISSUE OVER THE MESH. WE AIM FOR AT LEAST 5 CM INLAY COVERAGE FROM THE EDGES OF THE DEFECT. ENOUGH SUTURES ARE PLACED IN ORDER TO HAVE THE MESH BORDERS COMPLETELY SECURED TO THE TISSUE. AFTER THE POSTERIOR RECTUS SHEATH AND ITS DEFECT ARE CLOSED, WE PLACE SUBLAY A LARGE 30 X 30 CM ULTRAPRO MESH (ETHICON, LLC., CINCINNATI, OH, USA), A PARTIALLY ABSORBABLE MACRO-PORE LIGHTWEIGHT MESH. THIS MESH IS SECURED TO THE FASCIA USING 2-0 PROLENE U-SHAPED SUTURES. OVERLAP PAST THE HERNIA DEFECT NEEDED TO BE AT LEAST 5 CM, IF A SINGLE LARGE ULTRAPRO MESH WAS NOT ADEQUATE, THEN TWO ULTRAPRO MESHES WERE TIED TOGETHER. THE ANTERIOR FASCIA IS THEN CLOSED BY A RUNNING CONNELL TECHNIQUE USING A POLYDIOXANONE (PDS) 0 SUTURE. REPORTED COMPLICATIONS INCLUDED SURGICAL SITE HEMATOMA (N=3), INFECTION (N=1), SEROMA (N=2) AND HERNIA RECURRENCE (N=2). IN CONCLUSION, TO USE A BRIDGING MESH FOR THE POSTERIOR RECTUS SHEATH/PERITONEUM DURING MODIFIED RIVES-STOPPA VENTRAL HERNIA REPAIR WHEN IT IS UNABLE TO BE APPROXIMATED PRIMARILY IS EFFECTIVE, AND IS SAFE IN OUR PATIENT POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312023 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other