BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12238257 · Received July 28, 2021

    Report

    Report Number
    2210968-2021-06750
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    April 14, 2021
    Report Date
    July 7, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (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, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE (POSTOPERATIVE DYSPAREUNIA, NEW-ONSET PAINFUL INTERCOURSE AND FISTULA RECURRENCE)? PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE/STUDY? PLEASE SPECIFY. IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (POSTOPERATIVE DYSPAREUNIA, NEW-ONSET PAINFUL INTERCOURSE AND FISTULA RECURRENCE)? WAS THERE ANY MEDICAL/SURGICAL INTERVENTION PROVIDED FOR POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE (POSTOPERATIVE DYSPAREUNIA, NEW-ONSET PAINFUL INTERCOURSE AND FISTULA RECURRENCE)? IF YES, PLEASE SPECIFY. WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION:WORLD J GASTROENTEROL 2021 APRIL 14; 27(14): 1451-1464, DOI: 10.3748/WJG.V27.I14.1451, ISSN 1007-9327 (PRINT) ISSN 2219-2840.

    Description of Event or Problem · 1

    TITLE: STAPLED TRANSPERINEAL REPAIR FOR LOW- AND MID-LEVEL RECTOVAGINAL FISTULAS: A 5-YEAR EXPERIENCE AND COMPARISON WITH SUTURED REPAIR THIS WAS A RETROSPECTIVE COHORT STUDY CONDUCTED IN THE COLOPROCTOLOGY DEPARTMENT OF THE SIXTH AFFILIATED HOSPITAL OF SUN YAT-SEN UNIVERSITY (GUANGZHOU, CHINA). ADULT PATIENTS PRESENTING WITH RVF WHO WERE SURGICALLY MANAGED BY PERINEAL REPAIR BETWEEN MAY 2015 AND MAY 2020 WERE INCLUDED. AMONG THE 82 TOTAL PATIENTS, 37 UNDERWENT REPAIR WITH DIRECT SUTURING AND 45 UNDERWENT REPAIR WITH STAPLING. THE OVERALL MEAN AGE WAS 37.82 ± 12.63 YEARS, WITH DIVISION OF THE GROUPS INTO THOSE < 60 AND = 60 YEARS OF AGE. FOR THOSE PATIENTS IN GROUP 1, THE FISTULA WAS SHARPLY SEVERED WITH A SCALPEL, AFTER WHICH THE RECTUM AND VAGINA WERE CLOSED SEPARATELY WITH INTERRUPTED 2/0 OR 3/0 VICRYL (ETHICON ENDO-SURGERY INC.) SUTURES. NO SPECIFIC ATTEMPT WAS MADE TO REDUCE THE SUTURE LINE TENSION OR TO INTERPOSE TISSUE TO SUPPORT THE RECTOVAGINAL SEPTUM. IN GROUP 2 PATIENTS, THE ECHELON FLEX 60 ENDOPATH (ETHICON ENDO-SURGERY INC.) STAPLER WAS USED FOR FISTULA CLOSURE BY MEANS OF A STAPLED CARTRIDGE (3.5 MM STAPLE HEIGHT, 1.5 MM WHEN CLOSED). THE STAPLES LEFT ON THE VAGINAL WALL SIDE WERE REMOVED, AFTER WHICH THE DEFECT IN THE VAGINAL WALL WAS CLOSED BY DIRECT SUTURE. AFTER CLEAR IDENTIFICATION OF THE EDGES OF THE EXTERNAL ANAL SPHINCTER, THOSE CASES WHERE AN EXTERNAL ANAL SPHINCTER DEFECT HAD BEEN DEMONSTRATED BY PREOPERATIVE IMAGING UNDERWENT AN ATTENDANT ANAL SPHINCTEROPLASTY. EQUALLY, IF THERE WAS ANY TENSION ON THE SUTURE LINE, A LEVATORPLASTY WAS ALSO PERFORMED. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE DYSPAREUNIA, NEW-ONSET PAINFUL INTERCOURSE AND FISTULA RECURRENCE. IN CONCLUSION STAPLED TRANSPERINEAL REPAIR IS ADVANTAGEOUS FOR MANAGEMENT OF RVF, PROVIDING A HIGH PRIMARY HEALING RATE AND LOW RECURRENCE RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138039 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1