BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15006110 · Received July 13, 2022

    Report

    Report Number
    2210968-2022-05437
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    September 1, 2021
    Report Date
    July 13, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. COMPONENT CODE: (B)(4) DEVICE NOT RETURNED. CLINICAL CODE: (B)(4) URETEROILEAL ANASTOMOTIC STRICTURES. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: JOURNAL OF ENDOUROLOGY, VOLUME 35, NUMBER 9, SEPTEMBER 2021, PAGES 1350-1356, DOI: 10.1089/END.2020.0921.

    Description of Event or Problem · 0

    TITLE: ROBOT-ASSISTED CYSTECTOMY AND ILEAL CONDUIT FOR NEUROGENIC BLADDER: COMPARISON OF EXTRACORPOREAL VS LNTRACORPOREAL URINARY DIVERSION. THE AIM OF THE PRESENT STUDY WAS TO COMPARE THE PERIOPERATIVE OUTCOMES OF EXTRACORPOREAL (EXTRA) VS INTRACORPOREAL (INTRA) URINARY DIVERSION IN PATIENTS UNDERGOING ROBOTIC CYSTECTOMY AND ILEAL CONDUIT FOR NEUROGENIC BLADDER. BETWEEN 2011 AND 2020, 97 PATIENTS WHO UNDERWENT ROBOT-ASSISTED CYSTECTOMY AND ILEAL CONDUIT FOR NEUROGENIC BLADDER IN SIX CENTERS WERE INCLUDED IN THE STUDY. 66 OF THESE PATIENTS UNDERWENT EXTRACORPOREAL (EXTRA) URINARY DIVERSION AND 31 UNDERWENT INTRACORPOREAL (INTRA) URINARY DIVERSION. IN THE EXTRA GROUP, THERE WERE 35 MALES AND 31 FEMALES WITH A MEAN AGE OF 52.5 +/-1.7 YEARS AND A MEAN BMI OF 24.7+/-6.1 KG/M2. IN THE INTRA GROUP, THERE WERE 11 MALES AND 20 FEMALES WITH A MEAN AGE OF 56 +/-2.5 YEARS AND A MEAN BMI OF 27.3 +/-6.6 KG/M2. DURING THE EXTRA URINARY DIVERSION, AFTER THE URETEROILEAL ANASTOMOSIS WAS DONE OVER 6 TO L0F URETERAL STENTS USING EITHER THE WALLACE OR THE BRICKER TECHNIQUE THE STENTS WERE THEN GRASPED TO DELIVER THE ILEAL CONDUIT AT THE STOMA SITE AFTER A CRUCIATE INCISION HAS BEEN MADE IN THE RECTUS FASCIA AND (3) VICRYL (ETHICON) ANCHORING SUTURES HAVE BEEN TAKEN IN THE FASCIA. THE SAME TECHNIQUE WAS DONE FOR THE INTRA URINARY DIVERSION. THE MEAN FOLLOW-UP WAS 7.1 MONTHS. THE REPORTED COMPLICATIONS INCLUDE URINARY FISTULA (N=7), UROSEPSIS WITH SEPTIC SHOCK (N=1), AND URETEROILEAL ANASTOMOTIC STRICTURES (N=8). IN CONCLUSION, THE PERIOPERATIVE MORBIDITY OF ROBOTIC CYSTECTOMY AND ILEAL CONDUIT FOR NEUROGENIC BLADDER APPEARS TO BE RELATIVELY LIMITED COMPARED WITH THE HISTORICAL OPEN SERIES. POSSIBLY DUE TO THE RELATIVELY SMALL SAMPLE SIZE,NO DIFFERENCE WAS FOUND BETWEEN INTRA AND EXTRA URINARY DIVERSION IN TERMS OF PERIOPERATIVE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060656 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention