BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15276396 · Received August 23, 2022

    Report

    Report Number
    2210968-2022-06847
    Event Type
    Death
    Date Received
    August 23, 2022
    Date of Event
    January 1, 2022
    Report Date
    August 23, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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/DEATH DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? 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. RELATED EVENTS CAPTURED VIA 2210968-2022-06846. CITATION: BJU INT 2022; 129: 48¿53. HTTPS://DOI.ORG/10.1111/BJU.15375.

    Description of Event or Problem · 0

    TITLE: RETROSIGMOID ILEAL CONDUIT WITHOUT TRANSPOSITION OF THE LEFT URETER AFTER OPEN RADICAL CYSTECTOMY FOR BLADDER CANCER. THE AIM OF THIS STUDY IS TO ASSESS PERIOPERATIVE OUTCOMES, COMPLICATIONS, AND RATE OF URETERO¿ILEAL ANASTOMOTIC STRICTURE (UAS) IN PATIENTS UNDERGOING RETROSIGMOID ILEAL CONDUIT AFTER RADICAL CYSTECTOMY (RC). A TOTAL OF 97 PATIENTS (81 MALE AND 16 FEMALE; MEDIAN AGE OF 75 (68¿78) YEARS; MEDIAN BMI OF 26 (23¿29.4) KG/M2) RECEIVING RETROSIGMOID ILEAL CONDUIT AFTER OPEN RADICAL CYSTECTOMY FOR BLADDER CANCER BETWEEN MARCH 2016 AND JUNE 2020 AT TWO ACADEMIC CENTRES WERE PROSPECTIVELY COLLECTED. BRIEFLY, ~20 CM PROXIMAL TO THE ILEOCECAL VALVE, A 20-CM LONG ILEAL SEGMENT IS ISOLATED. WHILE THE INCISION OF THE MESENTERY AT THE LEVEL OF THE DISTAL END OF THE SELECTED ILEAL SEGMENT IS STRAIGHT, THE INCISION OF THE MESENTERY AT THE LEVEL OF THE PROXIMAL END IS LONGER, AND DIRECTED IN AN OBLIQUE PLANE IN ORDER TO ACCOMMODATE ITS RETROSIGMOID PASSAGE WITH NO TENSION. THE MESENTERY INCISION IS PERFORMED USING THE HARMONIC FOCUS® LONG SHEARS (ETHICON ENDO-SURGERY INC., CINCINNATI, OH, USA) OR THE LIGASURE¿ MARYLAND JAW (COVIDIEN, MANSFIELD, MA, USA). A SIDE-TO-SIDE ILEO¿ILEAL ANASTOMOSIS IS MADE USING GIA¿ 80-MM AND TA¿ 60-MM (COVIDIEN) STAPLERS. THE MESENTERY WINDOW IS CLOSED WITH INTERRUPTED SUTURES. THE PROXIMAL END OF THE ILEAL SEGMENT IS CLOSED WITH TA¿ 30-MM (COVIDIEN) STAPLER, PASSED THROUGH A WIDE, BLUNTLY DISSECTED, RETROSIGMOID TUNNEL FROM THE RIGHT TO THE LEFT BODY SIDE, AND FIXED TO THE PSOAS MUSCLE TENDON WITH TWO OR THREE INTERRUPTED 3-0 POLYGLACTIN 910 SUTURES (VICRYL®; ENDO-SURGERY INC.). THE REDUNDANT TRACT OF THE LEFT DISTAL URETER IS RESECTED IN ORDER TO OBTAIN A TENSION-FREE URETERO¿ILEAL ANASTOMOSIS WITHOUT KINKING, AND THE URETER IS ANASTOMOSED TO THE ANTERIOR FACE OF THE PROXIMAL PORTION OF THE ILEAL SEGMENT. THE RIGHT URETER IS ANASTOMOSED TO THE MOST CAUDAL POINT OF THE RIGHT DISTAL PORTION OF THE ILEAL SEGMENT. BOTH URETERO¿ILEAL ANASTOMOSES ARE MADE WITH FOUR INTERRUPTED POLYGLACTIN 910 SUTURES OVER A 6-F URETERIC CATHETER ACCORDING TO THE STANDARD DIRECT END-TO-SIDE NESBIT TECHNIQUE [12], AND ARE COVERED BY THE POSTERIOR PERITONEUM SO AS TO MINIMISE ANY RISK OF ANASTOMOTIC LEAKAGE OF URINE, IF ANY, INTO THE PERITONEAL CAVITY. FINALLY, AN ABDOMINAL NIPPLE STOMA IN THE RIGHT ILIAC FOSSA IS MADE. REPORTED COMPLICATIONS INCLUDE DEATH (N=2) FROM EARLY POSTOPERATIVE COMPLICATIONS WITHIN 3 MONTHS OF SURGERY; UNKNOWN EVENT REQUIRING INTRAOPERATIVE BLOOD TRANSFUSION (N=15); POSTOPERATIVE ANAEMIA (N=9) REQUIRING BLOOD TRANSFUSIONS; ILEUS (N=1) REQUIRING PARENTERAL NUTRITION; FEBRILE UTI (N=1) REQUIRING INTRAVENOUS ANTIMICROBIALS; SMALL BOWEL OBSTRUCTION (N=2) WHICH REQUIRED LYSE OF ILEAL ADHESIONS/ILEAL RESECTION; URETERO¿ILEAL ANASTOMOTIC STRICTURE INVOLVING THE RIGHT URETERO¿ILEAL ANASTOMOSIS (N=1) REQUIRING AN OPEN URETERO¿ILEAL RE-IMPLANTATION; POSTOPERATIVE BLEEDING (N=1) REQUIRING SURGICAL REVISION WITH HAEMOSTASIS; SEPSIS (N=1) REQUIRING INTRAVENOUS ANTIMICROBIALS + ICU MANAGEMENT; SMALL BOWEL PERFORATION (N=1) REQUIRING ILEAL RESECTION + ICU MANAGEMENT; DEHISCENCE OF ILEAL ANASTOMOSIS (N=1) REQUIRING ICU MANAGEMENT. IN CONCLUSION, THE RETROSIGMOID ILEAL CONDUIT IS A SAFE AND VALID OPTION FOR NON-CONTINENT URINARY DIVERSION AFTER RC, ENSURING A VERY LOW RISK OF UAS AT AN INTERMEDIATE-TERM FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2588164 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D