BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 16621697 · Received March 27, 2023

    Report

    Report Number
    2210968-2023-02099
    Event Type
    Injury
    Date Received
    March 27, 2023
    Report Date
    March 27, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2023-02100. CITATION: OBESITY SURGERY (2022) 32:3324¿3331 HTTPS://DOI.ORG/10.1007/S11695-022-06217-3.

    Description of Event or Problem · 0

    TITLE: LONG-TERM OUTCOMES OF LAPAROSCOPIC GASTRIC PLICATION FOR TREATMENT OF MORBID OBESITY: A SINGLE-CENTER EXPERIENCE. THIS STUDY WAS CONDUCTED TO ELUCIDATE THE LONG-TERM CONSEQUENCES OF LAPAROSCOPIC GASTRIC PLICATION (LGP). RETROSPECTIVE ANALYSIS OF PATIENTS WITH OBESITY UNDERWENT LGP AT OUR INSTITUTION BETWEEN MARCH 2010 AND SEPTEMBER 2014. OF THE 88 CONSECUTIVE PATIENTS IN THE STUDY, FOLLOW-UP DATA OUT TO 6 YEARS WAS AVAILABLE IN 60 LGP PATIENTS. THE MEAN AGE OF THE INCLUDED PATIENTS WAS 41.3 ± 10 YEARS. HARMONIC DEVICES WAS USED FOR DEVASCULARIZATION. PROLENE AND/OR ETHIBOND SUTURES WERE USED FOR PLICATION. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: (N=5) NAUSEA, VOMITING AND EPIGASTRIC PAIN. (N=?) DE NOVO GERD. (N=4) EROSIVE ESOPHAGITIS, 3 OF THEM HAD GRADE A REFLUX ESOPHAGITIS, AND THE OTHER ONE HAD GRADE B REFLUX ESOPHAGITIS. (N=1) MAJOR COMPLICATION AND REQUIRED EMERGENCY REOPERATION DUE TO EARLY LEAKAGE FROM THE PROXIMAL ONE-THIRD OF THE PLICATED GASTRIC FUNDUS (N=13) REOPERATIONS. IN CONCLUSION, AT THE 6-YEAR FOLLOW-UP VISIT, LGP HAS A MUCH LESS DURABLE EFFECT ON WEIGHT LOSS WITH A % EWL OF 32% AND A WEIGHT REGAIN OF 58.3% RESULTING IN A HIGH RATE OF REVISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431495 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention