BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 16626688 · Received March 28, 2023

    Report

    Report Number
    2210968-2023-02155
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    December 22, 2019
    Report Date
    March 28, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. RELATED EVENTS CAPTURED VIA: 2210968-2023-02140, 2210968-2023-02141, 2210968-2023-02142, 2210968-2023-02143, 2210968-2023-02144, 2210968-2023-02145, 2210968-2023-02146, 2210968-2023-02147, 2210968-2023-02148, 2210968-2023-02149, 2210968-2023-02150, 2210968-2023-02151, 2210968-2023-02152, 2210968-2023-02153, 2210968-2023-02154. CITATION CITE: EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 57 (2020) 1091¿1097 ORIGINAL ARTICLE HTTPS://DOI.ORG/10.1093/EJCTS/EZZ380.

    Description of Event or Problem · 0

    TITLE: REEXAMINING REMODELLING IN CHILDREN. THIS STUDY REVIEWED THE EXPERIENCE WITH ROOT REMODELLING IN PAEDIATRIC PATIENTS TO ANALYSE THE MID- TO LONG-TERM DURABILITY OF THIS APPROACH. ALL PATIENTS WHO UNDERWENT ROOT REMODELLING AT THE AGE OF 18 YEARS BETWEEN 1999 AND 2016 WERE EVALUATED. IN 2004, CUSP EFFECTIVE HEIGHT WAS MEASURED INTRAOPERATIVELY AND PROLAPSE WAS CORRECTED WITH CENTRAL PLICATION ON THE CUSP. SUTURE ANNULOPLASTY WAS INTRODUCED AFTER 2009 FOR ANNULAR DILATATION. AN EXTERNAL SUTURE ANNULOPLASTY WAS PERFORMED BEFORE CUSP REPAIR. INITIALLY, A BRAIDED POLYESTER SUTURE (ETHIBOND 2; ETHICON) WAS USED. REPORTED COMPLICATIONS INCLUDED PATIENT 1 2.8 YEARS OLD FEMALE WITH CUSP PROLAPSE , PATIENT 2 17 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 4 16 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 5 11 YEARS OLD FEMALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 6 17 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION PATIENT 7 8.1 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 8 12 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 9 14 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 10 9.3 YEARS OLD FEMALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 11 14 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 12 18 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 13 12 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 14 18 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 15 17 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 16 17 YEARS OLD MALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. PATIENT 17 14 YEARS OLD FEMALE WITH UNICUSPID VALVE HAD DEVELOPED MODERATE AORTIC REGURGITATION. IN CONCLUSION ROOT REMODELLING CAN ALSO BE PERFORMED IN CHILDREN WITH FAVOURABLE RESULTS BY APPROPRIATE CUSP REPAIR AND ANNULOPLASTY. VSRR WITH OUR APPROACH IS A VALID OPTION FOR PATIENTS WITH AORTIC REGURGITATION AND ROOT ANEURYSM, REGARDLESS OF PATIENTS¿ AGE, CONGENITAL DISORDER AND PREVIOUS CARDIAC OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28380 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Other