BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 23017441 · Received September 10, 2025

    Report

    Report Number
    2210968-2025-10315
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    January 22, 2025
    Report Date
    September 10, 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
    UK
    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 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J THORAC DIS. 2025 JAN 24;17(1):299-307. DOI: 10.21037/JTD-24-1395. EPUB 2025 JAN 22. PMID: 39975751; PMCID: PMC11833585. HTTPS://DOI.ORG/10.21037/JTD-24-1395.

    Description of Event or Problem · 0

    ADVANCED THYMIC EPITHELIAL TUMOUR RESECTION: VASCULAR RESECTION AND RECONSTRUCTION STRATEGY. THE AIM OF THE STUDY IS TO INTERROGATE THE AUTHORS' SERIES OF ADVANCED THYMIC EPITHELIAL TUMORS (TET) RESECTIONS. BETWEEN 2015 AND 2023, 31 PATIENTS WITH ADVANCED STAGE TET (STAGE III/IV) UNDERWENT SURGERY AT OPEN RESECTION, AND MAJOR VESSEL RECONSTRUCTION WAS REQUIRED IN 14 CASES (45%). EXTRA-PLEURAL PNEUMONECTOMY WAS REQUIRED IN 7 PATIENTS, PLEURECTOMY DECORTICATION IN 14 PATIENTS, DIAPHRAGMATIC RESECTION IN 10, AND CONCOMITANT CHEST WALL AND LUNG RESECTION IN 4 PATIENTS. ANASTOMOSES ARE ALL PERFORMED WITH CONTINUOUS 4-0 PROLENE, AND THE EXTRA-ANATOMIC BYPASS OF THE INNOMINATE TO THE RA, A CONTINUOUS 4-0 PROLENE SUTURE IS USED ON THE ATRIAL SIDE INCORPORATING MUSCULI PECTINATI INTO THE DISTAL END OF THE GRAFT. REPORTED COMPLICATIONS ARE PROLENE SUTURES. N=1 PATIENT 2: SEVERE POST-OPERATIVE HAEMOPTYSIS TREATMENT: NOT REPORTED. MORTALITY AS A RESULT OF SEVERE HAEMOPTYSIS POST-OPERATIVELY (BRONCHIAL VASCULAR INVASION WITH BREACH INTO THE AIRWAY) AND CONCURRENT CHEST SEPSIS. TREATMENT: N/A N=1 PATIENT 4: HOSPITAL ACQUIRED PNEUMONIA TREATMENT: REQUIRING MECHANICAL VENTILATION AND TRACHEOSTOMY FOR WEANING. N=1 PATIENT 5: BLEEDING WITH CARDIAC TAMPONADE TREATMENT: REQUIRING PERCUTANEOUS DRAINAGE. N=1 PATIENT 6: CARDIAC HERNIATION TREATMENT: REQUIRING REFASHIONING OF GORTEX MEMBRANE. N=1 PATIENT 8: HOSPITAL ACQUIRED PNEUMONIA TREATMENT: REQUIRING INTRAVENOUS ANTIBIOTICS. N=1 PATIENT 12: HAEMOTHORAX TREATMENT: REQUIRING DRAINAGE. IN CONCLUSION, ADVANCED STAGE TET REPRESENTS A COMPLEX AND RARE GROUP OF PATHOLOGIES WHICH REQUIRE MULTI-DISCIPLINARY INPUT, CAREFUL PRE-OPERATIVE PLANNING, AND SYSTEMIC BIOLOGICAL CONTROL WITH CHEMORADIATION. COMPLEX VASCULAR RESECTION AND RECONSTRUCTION IS SAFE AND ALLOWS FOR COMPLETE EN BLOC RESECTION BUT SHOULD BE PERFORMED AT HIGH VOLUME CENTRES BY HIGH VOLUME SURGEONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500840 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention