BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 22236695 · Received June 17, 2025

    Report

    Report Number
    2210968-2025-06971
    Event Type
    Death
    Date Received
    June 17, 2025
    Date of Event
    January 25, 2024
    Report Date
    June 17, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    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. WHAT WAS THE CAUSE OF DEATH? 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: DOI: 10.47009/JAMP.2024.6.1.330.

    Description of Event or Problem · 0

    TITLE: EFFICACY OF PROLENE VS VICRYL IN TRACHEAL RESECTION AND ANASTOMOSIS. THE AIM OF THIS STUDY IS TO COMPARE THE INCIDENCE OF MORBIDITY/MORTALITY DUE TO LEAKS AND LONG-TERM RECURRENCE OF TRACHEAL STENOSIS. BETWEEN JANUARY 2022 AND JUNE 2023, THERE WAS A TOTAL OF 66 CASES THAT REQUIRED TRACHEAL RESECTION AND ANASTOMOSIS. AMONG THEM, 32 PATIENTS UNDERWENT TRACHEAL RESECTION WITH PROLENE (GROUP P), AND THE REMAINING 34 UNDERWENT TRACHEAL RESECTION WITH VICRYL (GROUP V). REPORTED COMPLICATIONS ARE: GROUP P: N=6; LEAK FOLLOWING TRA (TRACHEAL RESECTION AND ANASTOMOSIS), TREATMENT: NOT REPORTED. GROUP V: N=1; LEAK FOLLOWING TRA (TRACHEAL RESECTION AND ANASTOMOSIS), TREATMENT: NOT REPORTED. N=3; MORTALITY DUE TO TRACHEA-RELATED COMPLICATIONS, TREATMENT: NONE. IN CONCLUSION, WE DEDUCED THAT VICRYL AND PROLENE PERFORM SIMILARLY IN REDUCING MORBIDITY (LEAK), BUT BOTH GROUPS' MORTALITY RATES REMAIN THE SAME. THEREFORE, TO ALLEVIATE THESE PROBLEMS, WE RECOMMEND USING PROLENE WHEN UNDERGOING TRACHEAL RESECTION AND ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33977 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R