BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 16597173 · Received March 23, 2023

    Report

    Report Number
    2210968-2023-01968
    Event Type
    Death
    Date Received
    March 23, 2023
    Date of Event
    October 28, 2021
    Report Date
    March 23, 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

    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/DEATH 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? HAS AN AUTOPSY BEEN PERFORMED FOR DEATH CASE? IF SO, CAN THE RESULTS BE SHARED? WOULD THE JOURNAL AUTHOR / PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: RING. J. CLIN. MED. 2021, 10, 5080. HTTPS://DOI.ORG/10.3390/JCM10215080.

    Description of Event or Problem · 0

    TITLE: RESULTS AFTER REPAIR OF FUNCTIONAL TRICUSPID REGURGITATION WITH A THREE-DIMENSIONAL ANNULOPLASTY RING. THIS STUDY REPORTS THE RESULTS USING A THREE-DIMENSIONAL ANNULOPLASTY RING (MEDTRONIC, CONTOUR 3D RING) FOR TRICUSPID VALVE REPAIR AND ANALYSIS OF RISK FACTORS. A COHORT OF 468 PATIENTS WHO UNDERWENT TV REPAIR (TVR) WITH A CONCOMITANT CARDIAC PROCEDURE FROM DECEMBER 2010 TO JANUARY 2017 WAS RETROSPECTIVELY ANALYZED. INTRA-ANNULAR ETHIBOND 3.0 SUTURES ((B)(4) GERMANY) WERE USED FOR RING FIXATION. COMPLETE FOLLOW-UP (FU) WAS ACHIEVED IN 95% OF PATIENTS, YIELDING A CUMULATIVE TOTAL OF 1217 PATIENT-YEARS AND A MEAN FU OF 2.52 2.0 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: (N=22) 30-DAY MORTALITY. IN CONCLUSION, TVR WITH THE CONTOUR 3D ANNULOPLASTY RING SHOWS LOW TR RECURRENCE AND REOPERATION RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28592 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D CONTOUR 3D RING, MEDTRONICS.