BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 15578786 · Received October 11, 2022

    Report

    Report Number
    2210968-2022-08329
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    August 26, 2020
    Report Date
    October 11, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 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 2210968-2022-08328 CITATION: SURGICAL ENDOSCOPY (2021) 35:3513¿3522 HTTPS://DOI. (B)(4).

    Description of Event or Problem · 0

    TITLE: COMPARISON OF SLEEVE GASTRECTOMY AND ROUX-EN-Y GASTRIC BYPASS AFTER FAILURE OF GASTRIC BANDING: A TWO-CENTER STUDY WITH A PROPENSITY SCORE-MATCHED ANALYSIS THIS RETROSPECTIVE OBSERVATIONAL STUDY AIMS TO COMPARE THE RESULTS OF THE REVISION OF GASTRIC BANDING (GB) BY SLEEVE GASTRECTOMY (SG) OR ROUX-EN-Y GASTRIC BYPASS (RYGB) IN A LARGE POPULATION IN TWO SPECIALIZED CENTERS, ONE PERFORMING PRIMARILY SLEEVE GASTRECTOMY (SG) AND THE OTHER ROUX-EN-Y GASTRIC BYPASS (RYGB). FROM JANUARY 2006 TO DECEMBER 2017, ALL PATIENTS UNDERGOING SLEEVE GASTRECTOMY (SG) OR ROUX-EN-Y GASTRIC BYPASS (RYGB) FOR WEIGHT REGAIN OR INSUFFICIENT WEIGHT LOSS AFTER GASTRIC BANDING (GB) (N = 293) WERE INCLUDED IN THIS TWO-CENTER (TWO FRENCH UNIVERSITY HOSPITALS) STUDY. 293 PATIENTS UNDERWENT SG (N = 186; SLEEVE GASTRECTOMY (SG) GROUP) OR ROUX-EN-Y GASTRIC BYPASS (RYGB) (N = 107; ROUX-EN-Y GASTRIC BYPASS (RYGB) GROUP) . THE SLEEVE GASTRECTOMY (SG) GROUP CONSISTED OF 186 PATIENTS (WOMEN: N = 163 AND MEN: N= 23) WITH A MEAN AGE OF 44.1 YEARS (22¿71). THE ROUX-EN-Y GASTRIC BYPASS (RYGB) GROUP CONSISTED OF 107 PATIENTS (WOMEN: N = 98 AND MEN N=9 ) WITH A MEAN AGE OF 45.3 YEARS (23¿66). DURING ROUX-EN-Y GASTRIC BYPASS (RYGB) AFTER GASTRIC BANDING (GB), HORIZONTAL GASTRIC TRANSECTION WAS PERFORMED USING A LINEAR 60 MM STAPLER ECHELON® (ETHICON ENDO SURGERY INC., CINCINNATI, OH, USA) WITH A BLUE CARTRIDGE (3.5 MM) 6 CM BELOW THE GASTROESOPHAGEAL JUNCTION. THEN VERTICAL TRANSECTION WAS PERFORMED WITH 2¿3 BLACK CARTRIDGES. GREATER OMENTUM PARTITION WAS ROUTINELY PERFORMED. THE BILIOPANCREATIC LIMB WAS APPROXIMATELY 70 CM IN LENGTH. ANTECOLIC GASTROJEJUNOSTOMY WAS PERFORMED MANUALLY WITH TWO RUNNING SUTURES OF PROLENE® 1 (ETHICON INC., CINCINNATI, OH, USA). JEJUNOJEJUNOSTOMY WAS PERFORMED USING A 60-MM ECHELON® LINEAR STAPLER (ETHICON ENDO SURGERY INC.) WITH A WHITE CARTRIDGE (2.5 MM) AND THE ENTEROTOMY WAS CLOSED WITH A RUNNING SUTURE OF PROLENE® 2/0 (ETHICON INC.). MESENTERIC DEFECTS WERE ROUTINELY CLOSED UTILIZING NON-ABSORBABLE SUTURES. REPORTED COMPLICATIONS INCLUDED: EARLY POST-OPERATIVE COMPLICATIONS FOR ROUX-EN-Y GASTRIC BYPASS (RYGB): (N=29) POST-OPERATIVE COMPLICATIONS.(N=5) LEAK ON THE GASTROJEJUNOSTOMY, WHO WERE REOPERATED AND IN THREE CASES (ALL PERFORMED BY LAPAROSCOPY). (N=2) BLEEDING, CONSISTING OF LAPAROSCOPIC HAEMOSTASIS. (N=4) STENOSIS/STRICTURE. (N=10) GRADE = 3 COMPLICATIONS. ADVERSE EVENTS AFTER THE THREE-MONTH FOLLOW- UP TO THE 2-YEAR FOLLOW-UP FOR ROUX-EN-Y GASTRIC BYPASS (RYGB) : (N=8) HAD DUMPING SYNDROME .(N=5) UNDERWENT LAPAROSCOPIC INTERNAL HERNIA REPAIR FOR CHRONIC ABDOMINAL PAIN.(N=3) UNDERWENT EMERGENCY SURGERY FOR SMALL BOWEL OBSTRUCTION ON INTERNAL HERNIA. (N=1) UNDERWENT INCISIONAL HERNIA REPAIR. (N=9) MARGINAL ULCERS. IT WAS CONCLUDED , THAT THE STUDY SHOWS THAT THE REVISION OF GASTRIC BANDING (GB) AFTER WEIGHT REGAIN OR INADEQUATE WEIGHT LOSS BY A SLEEVE GASTRECTOMY (SG) OR A ROUX-EN-Y GASTRIC BYPASS (RYGB) IS FEASIBLE, WITH A HIGHER RATE OF EARLY POST-OPERATIVE COMPLICATIONS FOR ROUX-EN-Y GASTRIC BYPASS (RYGB) . WEIGHT LOSS AT 2 YEARS FOLLOW-UP WERE SIMILAR, BUT THE MECHANISMS OF WEIGHT LOSS WERE PROBABLY DIFFERENT BETWEEN THE TWO REVISIONAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2764274 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention