BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19076175 · Received April 9, 2024

    Report

    Report Number
    2210968-2024-04115
    Event Type
    Death
    Date Received
    April 9, 2024
    Date of Event
    August 4, 2023
    Report Date
    April 9, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-04116. CITATIONS : JOURNAL OF CARDIOVASCULAR DISEASE RESEARCH. VOL.14 (4):1-6. (B)(6).

    Description of Event or Problem · 0

    TITLE : STUDY OF POSTOPERATIVE COMPLICATIONS AND LONG-TERM OUTCOMES OF TRACHEOESOPHAGEAL FISTULA REPAIR SURGERY. THE AIM OF THIS STUDY WAS TO STUDY POSTOPERATIVE COMPLICATIONS AND LONG-TERM OUTCOMES OF TRACHEOESOPHAGEAL FISTULA REPAIR AT A TERTIARY HOSPITAL. NEONATES WHO UNDERWENT SURGERY FOR TRACHEOESOPHAGEAL FISTULA AT OUR INSTITUTE DURING JANUARY 2011 TO DECEMBER 2021 (10 YEARS) WERE CONSIDERED FOR PRESENT STUDY. THERE WERE 119 MALE AND 53 FEMALE. THE TEF WAS TRANSFIXED AND DIVIDED, THE UPPER ESOPHAGEAL POUCH WAS IDENTIFIED AND DISSECTED, AN ATTEMPT WAS DONE TO DO A PRIMARY ESOPHAGO ESOPHAGEAL ANASTOMOSIS WITH INTERRUPTED SINGLE LAYER 6/0 VICRYL SUTURES OVER 6 FRENCH FEEDING TUBES. THE REPORTED COMPLICATIONS INCLUDED MORTALITY : POSTOPERATIVE SEPSIS (25 %) & POSTOPERATIVE PNEUMONITIS (30.23 %), ANASTOMOTIC LEAK (N=10.47 %), STRICTURE (N=11.63 %) AND RE - EXPLORATION (N=5.23 %). IN CONCLUSION, ALTHOUGH THERE HAS BEEN A MARKED IMPROVEMENT IN THE ANTENATAL DIAGNOSIS OF TRACHEOESOPHAGEAL FISTULA, STILL HIGH MORTALITY IS MAINLY DUE TO DIAGNOSIS 24 HOURS AFTER BIRTH, LOW BIRTH-WEIGHT & ASSOCIATED MAJOR ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513033 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R