BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 13559430 · Received February 18, 2022

    Report

    Report Number
    2210968-2022-01175
    Event Type
    Injury
    Date Received
    February 18, 2022
    Date of Event
    July 22, 2021
    Report Date
    February 18, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING 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? 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. (B)(4) THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-00804. CITATION: DOI: 10.1159/000518182.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: USE OF POLYPROPYLENE STRIPS FOR REINFORCEMENT OF THE CRUROPLASTY IN LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR: A RETROSPECTIVE COHORT STUDY. THE PURPOSE OF THE PRESENT STUDY WAS TO EVALUATE PERIOPERATIVE COMPLICATIONS AND TO ASSESS RECURRENCE RATE OF THE POLYPROPYLENE STRIP-REINFORCED CRUROPLASTY (PSRC) TECHNIQUE. A TOTAL OF 158 PATIENTS UNDERWENT LAPAROSCOPIC HIATAL SURGERY BETWEEN 2013 AND 2020. MEAN AGE WAS 65 YEARS (STANDARD DEVIATION 10.4), AND 119 PATIENTS WERE FEMALE (75.3%). ALMOST 50% OF SURGERIES TOOK PLACE BETWEEN 2018 AND 2020. IN THE CRURAL REPAIR, POLYPROPYLENE STRIPS OF 3 CM IN LENGTH AND 1 CM IN WIDTH WERE CUT FROM A STANDARD POLYPROPYLENE MESH (PROLENE; ETHICON INC., SOMERVILLE, NJ, USA) OR A POLYPROPYLENE MESH WITH COATING TO PREVENT ADHESION FORMATION (C.R. BARD, MURRAY HILL, NJ, USA). THE POSTERIOR CRURAL REPAIR WAS PERFORMED WITH WOVEN NON-ABSORBABLE SUTURES (ETHIBOND; ETHICON INC., SOMERVILLE, NJ, USA). FIRST, THE SUTURE WAS BROUGHT THROUGH THE STRIP AND THEN THROUGH THE LEFT CRURAL PILLAR, THE RIGHT PILLAR AND BACK THROUGH THE STRIP AGAIN. A KNOT PUSHER WAS USED TO GET TACTILE FEEDBACK OF THE TENSION OF THE REINFORCEMENT, MAKING SURE THE STRIPS ARE STITCHED TENSION FREE TO THE CRURAL PILLARS. THE NUMBER OF STRIPS USED WAS DETERMINED INTRAOPERATIVELY BY STRIPBY- STRIP APPROXIMATION. THIS ENABLED THE SURGEON TO PERFORM THE REPAIR FOR ALL 3 TYPES OF PEH. THE MOST VENTRAL SUTURES WERE TIED WITHOUT USING A STRIP TO AVOID DIRECT CONTACT WITH THE OESOPHAGUS. NORMALLY, ONE SUTURE WAS USED FOR THE VENTRAL SIDE. IF THE VENTRAL HIATUS WAS DEEMED TOO WIDE STILL, ANOTHER SUTURE WAS USED TO APPROXIMATE THE DEFECT. IN ADDITION, A 270° POSTERIOR TOUPET FUNDOPLICATION WAS PERFORMED TO AVOID REFLUX AND TO REINFORCE THE POSTERIOR CRURAL REPAIR. THE FUNDOPLICATION WAS CREATED BY PLACING TWO SUTURES BETWEEN THE WRAP AND SUTURING THIS AGAINST THE STRIPS AND THE CRURAL PILLARS, ACHIEVING A FIRM ATTACHMENT. THE MIDDLE SECTION OF THE FUNDOPLICATION WAS SUTURED TO THE RIGHT SIDE OF THE OESOPHAGUS, AND THE LEFT SIDE OF THE FUNDOPLICATION STITCHES WAS STITCHED TO THE LEFT SIDE OF THE OESOPHAGUS, WITH EXCEPTION OF THE MOST CRANIAL SUTURE, WHICH WAS PLACED TO THE LEFT SIDE OF THE DIAPHRAGM. BY FIXATING THE FUNDOPLICATION ON TO THE POLYPROPYLENE STRIPS, FRICTION WAS AVOIDED BETWEEN THE POLYPROPYLENE STRIPS AND THE OESOPHAGUS. REPORTED COMPLICATIONS INCLUDED N=13 RECURRENCES, N=25 RETURN TO PPI USE AND N=4 PERSISTENT DYSPHAGIA. IN CONCLUSION, THE FINDINGS FROM THIS STUDY SHOW A LOW INCIDENCE OF PERIOPERATIVE COMPLICATIONS AFTER PEH REPAIR WITH PSRC. COMPLICATIONS WERE NOT RELATED TO THE PSRC TECHNIQUE ITSELF. THE SHORT-TERM RECURRENCE RATE WAS LOW, AS WAS DYSPHAGIA AFTER SURGERY, AND NO MESH-RELATED COMPLICATIONS WERE OBSERVED. LONGER FOLLOW-UP IS NEEDED TO AFFIRM LOW RECURRENCE RATES. THE USE OF SMALL POLYPROPYLENE STRIPS TORE IN FORCE THE CRUROPLASTY IS A PROMISING CONCEPT AND A SAFE AND FEASIBLE TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3602 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown