BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 18299991 · Received December 11, 2023

    Report

    Report Number
    2210968-2023-09640
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    July 25, 2022
    Report Date
    December 11, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURGICAL ENDOSCOPY (2023) 37:2224¿2238. HTTPS://DOI.ORG/10.1007/S00464-022-09434-0.

    Description of Event or Problem · 0

    TITLE: LONG-TERM WEIGHT LOSS AFTER BARIATRIC PROCEDURES FOR MORBIDLY OBESE ADOLESCENTS AND YOUTH: A SINGLE-INSTITUTION ANALYSIS WITH UP TO 19-YEAR FOLLOW-UP THE OBJECTIVE OF THIS STUDY IS TO BETTER CHARACTERIZE THE LONG-TERM EFFECT OF THESE PROCEDURES IN YOUTH, WITH EMPHASIS ON OPTIMIZING SURGICAL SELECTION IN THIS AGE GROUP. BETWEEN NOVEMBER 2001 AND NOVEMBER 2019, A TOTAL OF 167 PATIENTS AGED 15¿24 YEARS WHO UNDERWENT ONE OF THREE LAPAROSCOPIC BARIATRIC PROCEDURES AND WERE PROSPECTIVELY MONITORED OVER 19 YEARS. LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB, N = 71), LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB, N = 22), AND LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG, N=74). PATIENTS UNDERGOING LRYGB HAD A LONGER MEDIAN HOSPITAL STAY LRYGB VS. 1.0 LAGB VS. 1.0 LSG, AND 6/71 REQUIRED POSTOPERATIVE ENDOSCOPIC DILATATION. LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB) PROCEDURES WERE PERFORMED VIA A PARS FLACCIDA APPROACH INVOLVING TWO GASTROGASTRIC PLICATION SUTURES APPLIED ANTEROLATERALLY USING NONABSORBABLE 2¿0 ETHIBOND® POLYETHYLENE TEREPHTHALATE SUTURES (ETHICON ENDO-SURGERY, CINCINNATI, OHIO, USA); THESE PATIENTS WERE EITHER ADMITTED FOR OVERNIGHT OBSERVATION OR DISCHARGED ON THE DAY OF PROCEDURE. LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) SURGERIES EMPLOYED AN ECHELON FLEX¿ 60 POWERED ENDOCUTTER (ETHICON ENDO-SURGERY, CINCINNATI, OHIO, USA) TO EXCISE THE GASTRIC FUNDUS AND BODY OVER A 34-FRENCH GASTRIC LAVAGE TUBE, STARTING 4 CM FROM THE PYLORUS AND ENDING 1 CM TO THE LEFT OF THE ANGLE OF HIS. REPORTED COMPLICATIONS INCLUDED ENDOSCOPIC DILATATION (N=6), AND LYSIS OF ADHESIONS (N=1). IN CONCLUSION, ALL PROCEDURES PROVIDED SIGNIFICANT AND DURABLE WEIGHT LOSS. LRYGB PATIENTS ACHIEVED THE BEST AND MOST SUSTAINED WEIGHT LOSS. LSG PATIENTS EXPERIENCED SECOND-BEST WEIGHT LOSS BETWEEN 1 AND 5 YEARS, WITH LOWEST CHANCE OF REOPERATION. LAGB PATIENTS HAD THE LEAST WEIGHT LOSS AND THE HIGHEST REOPERATION RATE. COMPARED TO OTHER FACTORS, TYPE OF BARIATRIC PROCEDURE WAS INDEPENDENTLY PREDICTIVE OF SUCCESSFUL WEIGHT LOSS OVER TIME. MORE STUDIES WITH LONG-TERM FOLLOW-UP ARE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045238 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention