BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE RELOAD FOR ECHELON 60

    MDR report key: 15667871 · Received October 25, 2022

    Report

    Report Number
    3005075853-2022-07210
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    August 26, 2020
    Report Date
    December 23, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001775
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EVENT DATE: PUBLICATION DATE, EXACT EVENT DATE UNK. BATCH # UNK. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/23/2022 D1: BRAND NAME. D4: CATALOG. D4: UNIQUE IDENTIFIER ( UDI).

    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. AUTHOR: ANTOINE VALLOIS, LIONEL REBIBO, YANNICK LE ROUX, ABDENNACEUR DHAHRI, ARNAUD ALVES, JEAN-MARC REGIMBEAU. CITATION: SURGICAL ENDOSCOPY (2021) 35:3513¿3522 HTTPS://DOI.ORG/10.1007/S00464-020-07809-9. 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
    2886860 BLUE RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. GST60B 10705036001775

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention