BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12619392 · Received October 12, 2021

    Report

    Report Number
    2210968-2021-09573
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    March 24, 2021
    Report Date
    September 17, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (REPAIR FAILURE/NOT SUCCESSFULLY HEALED) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (REPAIR FAILURE/NOT SUCCESSFULLY HEALED)? WERE THESE CASES REQUIRED SURGICAL/MEDICAL INTERVENTION? 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: INTERNATIONAL JOURNAL OF SURGERY OPEN (2021); 32(100335):1-6. HTTPS://DOI.ORG/10.1016/J.IJSO.2021.100335. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: RECTOVAGINAL FISTULAS, OUTCOMES OF VARIOUS SURGICAL REPAIR AND PREDICTIVE FACTORS OF HEALING SUCCESS. A RETROSPECTIVE COHORT STUDY OF 40 CASES THE MAIN OBJECTIVE OF THIS RETROSPECTIVE COHORT STUDY IS TO ASSESS THE OUTCOMES OF SURGICAL REPAIR OF RECTOVAGINAL FISTULAS AND FACTORS THAT PREDICT REPAIR FAILURE. BETWEEN FEBRUARY 2015 AND DECEMBER 2019, A TOTAL OF 40 PATIENTS PRESENTED WITH RECTOVAGINAL FISTULAS OF DIFFERENT ETIOLOGIES HAD BEEN ENROLLED. AGE RANGES BETWEEN 23 AND 65 YEARS (MEAN 41.6 YEARS). THE SURGICAL PROCEDURES INCLUDED TRANS-ANAL ENDORECTAL ADVANCEMENT FLAP (20 PATIENTS, 50%), TRANS-VAGINAL PURSE-STRING INVERSION REPAIR (8 PATIENTS, 20%), TRANS-PERINEAL APPROACH (4 PATIENTS, 10%) AND TRANSABDOMINAL REPAIR (8 PATIENTS, 20%). IN THE TRANSABDOMINAL REPAIR, THE RECTUM AND THE VAGINA ARE CLOSED WITH INTERRUPTED CHROMIC CATGUT OR VICRYL SUTURES WITHOUT BOWEL RESECTION. THE AVERAGE FOLLOW-UP PERIOD WAS 24 MONTHS (12-36 MONTHS). REPORTED COMPLICATIONS INCLUDE REPAIR FAILURE/NOT SUCCESSFULLY HEALED (N=4). IN CONCLUSION, FOR LOW SIMPLE RECTOVAGINAL FISTULAS, LOCAL REPAIR IS PREFERRED OPTION. COMPLEX, HIGH TYPE AND RECURRENT FISTULAS NECESSITATE TRANS-ABDOMINAL APPROACH. HISTORY OF PRIOR SURGICAL REPAIR AND ETIOLOGY ARE THE MAIN RISK FACTOR FOR REPAIR FAILURE. DIVERTING COLOSTOMY DID NOT INCREASE THE OVERALL HEALING RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514422 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1