BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 22077612 · Received May 23, 2025

    Report

    Report Number
    2210968-2025-05810
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    November 6, 2024
    Report Date
    June 19, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: J CARDIOTHORAC SURG. 2024 NOV 6;19(1):623. HTTPS://DOI.ORG/10.1186/S13019-024-03122-X. PMID: 39506802; PMCID: PMC11539628.

    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. CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE: FUNGAL ENDOCARDITIS AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION COMPLICATED WITH PSEUDOANEURYSM OF THE ASCENDING AORTA. THE AIM OF THE STUDY IS TO DESCRIBE A CASE OF A 75-YEAR-OLD MALE PATIENT WHO DEVELOPED FUNGAL ENDOCARDITIS CAUSED BY CANDIDA ALBICANS, COMPLICATED BY AN AORTIC PSEUDOANEURYSM. IN (B)(6) 2021, THE PATIENT EXPERIENCED PROSTHETIC DYSFUNCTION AND UNDERWENT PERCUTANEOUS AORTIC VALVE-IN-VALVE REPLACEMENT USING A 26 MM COREVALVE EVOLUT R PROSTHESIS. IN (B)(6) 2021, HE UNDERWENT COLECTOMY DUE TO PT1 PN0 M0 COLON CANNCER. ADDITIONALLY, MERSILENE 2-0 MATTRESS SUTURES WAS USED TO SECURED THE AORTIC VALVE REPLACEMENT USING A 23 MM EDWARDS INSPIRIS BOVINE BIOPROSTHESIS IN THE ANNULUS. REPORTED COMPLICATIONS: 75-YEAR-OLD MALE (N=1), MERSILENE 2-0 SUTURE (ETH), MEDIASTINAL BLEEDING, TREATMENT: RE-OPERATION. PLEURAL BLEEDING, TREATMENT: RE-OPERATION. IN CONCLUSION, AORTIC PSEUDOANEURYSM ASSOCIATED WITH ENDOCARDITIS IS A SERIOUS COMPLICATION FOLLOWING VALVE REPLACEMENT, CARRYING A HIGH MORTALITY RATE. THE PREFERRED TREATMENT APPROACH INVOLVES SURGICAL INTERVENTION COMBINED WITH ANTIMICROBIAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320872 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention