BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12583447 · Received October 6, 2021

    Report

    Report Number
    2210968-2021-09247
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    September 16, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. EVENTS WERE SUBMITTED VIA 2210968-2021-09246, AND 2210968-2021-09248. CITATION: CHAKRABORTY AND VYAS FR J UROL (2021) 27:47. HTTPS://DOI.ORG/10.1186/S12301-021-00150-0.

    Description of Event or Problem · 1

    TITLE: DORSAL VAGINAL GRAFT URETHROPLASTY IN FEMALE URETHRAL STRICTURE: A CONTEMPORARY SERIES. THIS STUDY AIMS TO DESCRIBE THE TECHNIQUE OF DORSAL ONLAY VAGINAL GRAFT URETHROPLASTY (DVGU) WITH ITS IMPACT ON THE FLOW RATE, SYMPTOM IMPROVEMENT, SUCCESS RATE AND COMPLICATIONS. FROM JANUARY 2015 TO OCTOBER 2017, WOMEN WHO UNDERWENT DORSAL ONLAY VAGINAL GRAFT URETHROPLASTY (DVGU) WERE IDENTIFIED AND REVIEWED. 24 PATIENTS WERE IDENTIFIED WITH A MEAN AGE OF 46.54 YEARS (RANGE 38¿55 YEARS). DURING GRAFT ANASTOMOSIS, THE FREE GRAFT IS DEFATTED, TRIMMED (ACCORDING TO THE ESTIMATED URETHRAL DEFECT) AND PLACED IN NORMAL SALINE. THE GRAFT IS NOW SUTURED IN PLACE.THE GRAFT¿S MUCOSAL SURFACE SHOULD FACE THE URETHRAL LUMEN WHILE SUTURING WITH TWO 4¿0 POLYGLACTIN 910 (VICRYL) SUTURES. EACH SUTURE IS PLACED AT THE APEX OF THE URETHROTOMY DEFECT (OUTSIDE-IN) AND THEN ONTO THE GRAFT-APEX (INSIDE OUT). ONE SUTURE IS TO BE RUN ON THE LEFT SIDE, AND THE OTHER SUTURE IS TO BE RUN ON THE RIGHT SIDE, THUS SUTURING THE LEFT AND RIGHT MARGINS OF THE GRAFT TO CORRESPONDING MARGINS OF THE URETHRAL DEFECT . IN ADDITION, TWO TO THREE 3¿0 POLYGLACTIN 910 (VICRYL) QUILTING SUTURES ARE PLACED CENTRALLY (AT 12 O¿CLOCK POSITION) TO ATTACH THE GRAFT TO THE PERIURETHRAL TISSUE TO MINIMISE SLIDING ESPECIALLY IN THE FIRST 48 H. THE MEAN FOLLOW- UP PERIOD WAS 22.62 MONTHS (RANGE 12¿36 MONTHS) . NINETEEN OF THE 24 PATIENTS HAD > 24 MONTHS OF FOLLOW-UP. REPORTED COMPLICATIONS INCLUDED: (N=2) HAD PREOPERATIVE URINARY URGENCY AND FREQUENCY AND CONTINUED TO EXPERIENCE IRRITATIVE SYMPTOMS AFTER SURGERY. (N=4) PATIENTS WHO CONTINUED TO HAVE RAISED (POST-VOID RESIDUAL VOLUME) PVR, BUT WITHOUT ANY UTI OR DISCOMFORT. HAVING AN ACCEPTABLE FLOW AT ONE-YEAR FOLLOW-UP, THREE WOMEN (N=3) , (SI NO. 3) A (B)(6) YEAR-OLD , (SI NO. 8) A (B)(6) YEAR-OLD AND (SI NO 12) A (B)(6) YEAR-OLD, STARTED TO EXPERIENCE POOR AFTERWARDS TO REACH A QMAX < 10 ML/S AT 18-MONTHS FOLLOW-UP.ALL OF THEM REVEALED STRICTURE RECURRENCE AT THE PROXIMAL GRAFT-URETHRAL ANASTOMOSIS ON URETHROSCOPY. THEY REQUIRED DILATATION BY THEIR LOCAL UROLOGISTS. HOWEVER, TWO OF THEM GOT. STABILISED WITH WEEKLY SOFT-DILATATION (BY NELATON CATHETER) OVER THE NEXT SIX MONTHS AND DID NOT REQUIRE FURTHER INTERVENTION. THE THIRD PATIENT EXPERIENCED A SHORT-LIVED RESPONSE TO REPEATED DILATATIONS. HOWEVER, SHE CHOOSES TO HAVE LONG-TERM CLEAN INTERMITTENT SELF-CATHETERISATION (CISC) OVER REDO-SURGERY.THE FAILURE RATE WAS (3 OUT OF 24 CASES) AT A MEAN FOLLOW-UP OF 22.6 MONTHS. IT WAS CONCLUDED, DORSAL ONLAY VAGINAL GRAFT URETHROPLASTY (DVGU) REPRESENTS A SIMPLE SURGICAL TECHNIQUE WITH GOOD REPRODUCIBILITY AND AN EFFECTIVE LOW-MORBIDITY RECONSTRUCTIVE SURGERY FOR FUS. THE PRESENT EXPERIENCE SHOWS THAT DORSAL ONLAY VAGINAL GRAFT URETHROPLASTY (DVGU) HAS THE POTENTIAL TO PROVE AS ONE OF THE SIMPLE ONE-TIME CURATIVE OPTIONS WITH A HIGH SUCCESS RATE IN FEMALE URETHRAL STRICTURE DISEASE, WHICH IS OFTEN CONSIDERED A DIFFICULT TO- MANAGE PROBLEM REQUIRING REPEATED DILATATIONS AND CLEAN INTERMITTENT SELF-CATHETERISATION (CISC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484205 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention