BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 24691183 · Received March 25, 2026

    Report

    Report Number
    2210968-2026-03086
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    July 18, 2025
    Report Date
    March 25, 2026
    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

    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 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HERNIA. 2025 JUL 18;29(1):235. DOI: 10.1007/S10029-025-03416-6. PMID: 40679643; PMCID: PMC12274264. HTTPS://DOI.ORG/10.1007/S10029-025-03416-6.

    Description of Event or Problem · 0

    FRAILTY PREDICTS RECURRENCE AFTER LAPAROSCOPIC NISSEN FUNDOPLICATION WITH MESH CRUROPLASTY FOR GIANT SLIDING HIATAL HERNIA WITH SEVERE REFLUX ESOPHAGITIS IN ELDERLY PATIENTS: A MULTICENTER RETROSPECTIVE STUDY. THIS STUDY ASSESSED THE RATE OF RECURRENT SLIDING HH FOLLOWING MESH CRUROPLASTY AND LAPAROSCOPIC NISSEN FUNDOPLICATION (LNF), AND EVALUATED FRAILTY AS A POTENTIAL RISK FACTOR OF RECURRENCE. THIS RETROSPECTIVE MULTICENTER STUDY INCLUDED 266 PATIENTS AGED = 60 YEARS WHO UNDERWENT MESH CRUROPLASTY AND LNF FOR GIANT SLIDING HH (> 5 CM) WITH SEVERE REFLUX ESOPHAGITIS (DEMEESTER SCORE > 100) BETWEEN MARCH 2016 AND MARCH 2022, STRATIFIED INTO NON-RECURRENCE (N = 241) AND RECURRENCE (N = 25) HH. THE MEAN AGE WAS 66.92 ± 4.3 YEARS VS. 67.79 ± 3.7 YEARS IN THE NON-RECURRENCE AND RECURRENCE GROUP, RESPECTIVELY. POSTERIOR HIATOPLASTY WAS DONE BY APPROXIMATION OF THE DIAPHRAGMATIC CRURA POSTERIOR TO THE ESOPHAGUS USING 3¿4 INTERRUPTED NON-ABSORBABLE BRAIDED POLYESTER SUTURES (ETHIBOND EXCEL, ETHICON INC., SOMERVILLE, NJ, USA). THE SUTURES WERE DEEPLY PLACED, INCLUDING THE SUBDIAPHRAGMATIC FASCIA, IMMEDIATE SEQUENTIAL SUTURE TYING TO PREVENT FOULING, AND OBJECTIVE HIATAL CALIBRATION. A 360° NISSEN FUNDOPLICATION WAS THEN CONSTRUCTED USING 2¿3 INTERRUPTED NON-ABSORBABLE SUTURES (ETHIBOND¿ 2 - 0, ETHICON) TO CREATE A 2-CM POSTERIOR WRAP. REPORTED COMPLICATIONS INCLUDE: 3¿4 ETHIBOND EXCEL, ETHIBOND¿ 2 - 0 (ETHICON) SUPERFICIAL SURGICAL SITE INFECTIONS (N=2) TREATMENT: OPEN WOUND IN BED. ORGAN/SPACE INFECTIONS (N=2) TREATMENT: REOPERATION. ILEUS (N=1) TREATMENT: CONSERVATIVE TREATMENT. PULMONARY COMPLICATIONS (INFECTION/ATELECTASIS) (N=3) TREATMENT: ICU ADMISSION WITH CARDIORESPIRATORY SUPPORT. INTRA-ABDOMINAL COLLECTION (N=2) TREATMENT: SONAR GUIDED ASPIRATION. RECURRENT HIATAL HERNIA (N=25) TREATMENT: RE-OPERATION (N=12 (LAPAROSCOPIC REDO SURGERY (N=8), OPEN ABDOMINAL REDO SURGERY(N=4). DYSPHAGIA (N=11) TREATMENT: NOT REPORTED. GAS BLOAT SYNDROME (N=4) TREATMENT: NOT REPORTED. POSTOPERATIVE DYSPHAGIA (N=11) TREATMENT: NOT REPORTED. POSTOPERATIVE ESOPHAGITIS (N=24) TREATMENT: NOT REPORTED. CRURAL SUTURES BREAKDOWN (N=5). IN CONCLUSION, FRAILTY WAS AN INDEPENDENT PREDICTOR OF HH RECURRENCE. INTEGRATING FRAILTY ASSESSMENT INTO PREOPERATIVE WORKFLOWS COULD OPTIMIZE PATIENT SELECTION AND OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748236 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention