BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 19055723 · Received April 5, 2024

    Report

    Report Number
    2210968-2024-03944
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    March 28, 2023
    Report Date
    April 5, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATIONS: SURGICAL ENDOSCOPY.VOL.37:5295¿5302 HTTPS://DOI.ORG/10.1007/S00464-023-10005-0. RELATED EVENTS CAPTURED VIA 2210968-2024-03944, 2210968-2024-03945.

    Description of Event or Problem · 0

    TITLE : HIATUS HERNIA REPAIR WITH A NEW-GENERATION BIOSYNTHETIC MESH: A 4-YEAR SINGLE-CENTER EXPERIENCE. THE STUDY IS AIMED TO ASSESS OUTCOMES AFTER HH REPAIR WITH THIS NEW GENERATION OF MESH AT OUR INSTITUTION. BETWEEN DECEMBER 2017 AND JULY 2022, 97 PATIENTS (ELECTIVE PRIMARY CASES N = 76, REDO CASES N = 13, EMERGENCY CASES N = 8) UNDERWENT HH WITH BSM AUGMENTATION. INDICATIONS IN ELECTIVE AND EMERGENCY CASES WERE PARAESOPHAGEAL (TYPE II¿IV) HH IN 83%, AND LARGE TYPE I HH IN 4%. RECONSTRUCTION OF THE HIATUS WAS THEN PERFORMED IN ALL PATIENTS WITH A POSTERIOR CRURORRHAPHY USING 3¿4 SINGLE FORM-8 STITCHES (ETHIBOND 0, ETHICON, ZUG, SWITZERLAND). AFTER PLACEMENT AROUND THE ABDOMINALESOPHAGUS IN AN ONLAY FASHION, THE MESH WAS FIXED AT THE HIATUS WITH 4¿6 ABSORBABLE SUTURES (VICRYL 3-0, ETHICON). THE REPORTED COMPLICATIONS INCLUDED HIATUS HERNIA RECURRENCE : ANATOMICAL FAILURE (N=8), REFLUX (N=7), DYSPHAGIA (N=5), AND REGURGITATION (N=1). IN CONCLUSION, OUR DATA SUGGEST THAT HH REPAIR WITH BSM AUGMENTATION IS FEASIBLE AND SAFE WITH LOW PERIOPERATIVE MORBIDITY AND ACCEPTABLE POSTOPERATIVE FAILURE RATES AT EARLY TO MID-TERM FOLLOW-UP. BSM MAY BE A USEFUL ALTERNATIVE TO NON-RESORBABLE MATERIALS IN HH SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821946 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other