BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 24650756 · Received March 20, 2026

    Report

    Report Number
    2210968-2026-02879
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    June 24, 2025
    Report Date
    March 20, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: STRUCT HEART. 2025 JUN 24;9(8):100683. HTTPS://DOI.ORG/10.1016/J.SHJ.2025.100683. PMID: 40894366; PMCID: PMC12399273.

    Description of Event or Problem · 0

    TITLE: FEASIBILITY, EFFICACY, AND SAFETY OF THE MITRAL ANNULO-TRIPSY IN EXTREME RISK PATIENTS. THIS STUDY AIMS TO DESCRIBE A MODIFIED TECHNIQUE USING LARGER IVL BALLOONS TO ENSURE MAXIMAL ANNULAR CONTACT AND DELIVERY OF ULTRASONIC SHOCKWAVES TO RESTORE MITRAL LEAFLET PLIABILITY AND REDUCE TRANSVALVULAR GRADIENTS WITHOUT THE NEED FOR NONCOMPLIANT VALVULOPLASTY BALLOONS. BETWEEN 2024 AND 2025, A TOTAL OF 7 PATIENTS WITH SEVERE MAC AND SEVERE MS WERE SELECTED TO UNDERGO THE MATRIX PROCEDURE USING ETHIBOND SUTURE FOR CLOSURE. REPORTED COMPLICATIONS ARE: ETHIBOND. N=1 RESIDUAL ATRIAL SEPTAL DEFECT WITH BIDIRECTIONAL SHUNTING. TREATMENT: CLOSED USING A 10 MM ATRIAL SEPTAL OCCLUDER DEVICE. IN CONCLUSION, IN THIS PRELIMINARY MULTICENTER EXPERIENCE, WE DEMONSTRATE THE FEASIBILITY, EFFICACY, AND SAFETY OF THE MATRIX TECHNIQUE IN A COHORT OF PATIENTS WITH SEVERE MS SECONDARY TO MAC. LARGER PROSPECTIVE STUDIES IN THIS HIGH-RISK PATIENT POPULATION ARE REQUIRED TO VALIDATE THIS NEW TECHNIQUE. MATRIX OFFERS AN ALTERNATIVE TREATMENT OPTION FOR MAC IN THOSE WHO ARE AT PROHIBITIVE SURGICAL RISK AND WHERE TMVR IS CONTRAINDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716852 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention