BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT

    MDR report key: 13565272 · Received February 19, 2022

    Report

    Report Number
    2210968-2022-01204
    Event Type
    Injury
    Date Received
    February 19, 2022
    Date of Event
    October 19, 2021
    Report Date
    February 19, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K810428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). (B)(4). 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: HTTPS://DOI.ORG/10.1007/S00464-021-08828-W. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL MESH AND PROLENE POLYPROPYLENE MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS INVOLVED? PATIENT DEMOGRAPHICS? EVENT RELATED TO PROLENE MESH DEVICE REPORTED VIA MW # 2210968-2022-01205.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: IMPACT OF SURGICAL REPAIR ON TYPE IV PARAESOPHAGEAL HERNIAS (PEHS). THIS STUDY AIMS TO COMPARE SURGICAL OUTCOMES AFTER LAPAROSCOPIC REPAIR BETWEEN TYPE III AND IV PARAESOPHAGEAL HERNIAS (PEHS). BETWEEN JANUARY 2006 AND JANUARY 2020, A TOTAL OF 103 PATIENTS (N=70 MEN; N=33 WOMEN) WHO UNDERWENT LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR (LPEHR) AT THE DEPARTMENT OF DIGESTIVE SURGERY OF THE NOUVEL HOSPITAL CIVIL (NHC) IN STRASBOURG, FRANCE WERE INCLUDED. MEAN AGE WAS 67.88 ± 13.25 YEARS, AND MEAN BMI WAS 29.21 ± 5.84 KG/ M2. THE MAIN PRESENTING SYMPTOMS WERE GERD IN 50 PATIENTS (48.54%) AND PYROSIS IN 20 PATIENTS (19.42%). MOST PATIENTS UNDERWENT PRIMARY REPAIR IN AN ELECTIVE SETTING, I.E. 92 PATIENTS (89.32%) AS COMPARED TO 11 PATIENTS (10.68%) WHO HAD A REDO SURGERY. GASTRIC VOLVULUS WAS PRESENT IN 16 CASES (15.53%). ONLY SIX PATIENTS (5.83%) REQUIRED AN EMERGENCY SURGERY. INTRAOPERATIVE EVALUATION SHOWED THAT TYPE III PEHS WERE THE MOST FREQUENT ONES AS THEY WERE PRESENT IN 91 PATIENTS (88.35%) VS. 12 PATIENTS (11.65%) IN TYPE IV PEHS. IN TYPE IV PEHS, THE ADDITIONAL HERNIATED ORGAN WAS THE COLON IN 11 PATIENTS (91.6%) WITH THE PANCREAS IN 3 PATIENTS (25%), AND THE FIRST PORTION OF THE DUODENUM IN ONE PATIENT ONLY. NISSEN FUNDOPLICATION WAS THE MOST COMMONLY USED SURGICAL TECHNIQUE IN 63 PATIENTS (61.17%) FOLLOWED BY TOUPET FUNDOPLICATION IN 13 PATIENTS (12.62%). AN EXTENSIVE MOBILIZATION OF THE MEDIASTINAL ESOPHAGUS WAS PERFORMED AS PART OF THE SURGICAL TECHNIQUE TO PRECLUDE AXIAL TENSION. ESOPHAGEAL LENGTHENING USING A COLLIS GASTROPLASTY WAS PERFORMED IN 14 PATIENTS (13.59%). ONLY ONE PATIENT REQUIRED A SLEEVE GASTRECTOMY DUE TO GASTRIC FUNDUS NECROSIS. MESH REINFORCEMENT WAS PERFORMED IN 64 PATIENTS (62.14%), A POLYGLACTIN 910 MESH (VICRYL; ETHICON, SOMERVILLE, NJ, UNITED STATES) WAS USED IN (N=56) PATIENTS WHILE A POLYPROPYLENE MESH (PROLENE®; ETHICON INC. SOMERVILLE, NJ, UNITED STATES) WAS USED IN ONLY (N=3) PATIENTS. MEAN OPERATIVE TIME WAS 147.43 ± 76.03 MIN. ONLY ONE PATIENT (0.97%) REQUIRED CONVERSION TO THORACOTOMY BECAUSE OF PULMONARY VEIN INJURY, WHICH OCCURRED DURING THE TRANSMEDIASTINAL DISSECTION OF A RECURRENT PARAESOPHAGEAL HERNIA (PEH). REPORTED COMPLICATIONS INCLUDED N=3 CLAVIEN DINDO I, N=4 CLAVIEN DINDO II, N=1 CLAVIEN DINDO IIIA, N=5 CLAVIEN DINDO IIIB, N=1 30-DAY POSTOP READMISSION, N=1 CHRONIC DYSPHAGIA, N=1 EPIGASTRIC PAIN, N=16 RECURRENCE AND N=3 REOPERATION. IN CONCLUSION, PATIENTS WITH TYPE IV PEHS APPEAR TO BE OLDER AND FRAILER. THE HIGHER INCIDENCE OF POSTOPERATIVE COMPLICATIONS IN PATIENTS WITH TYPE IV PEHS SHOULD ADVOCATE FOR A PRECISE INDICATION FOR SURGICAL TREATMENT, WHICH SHOULD BE PERFORMED IN CENTERS OF EXPERTISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681302 VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention