BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20597685 · Received November 4, 2024

    Report

    Report Number
    2210968-2024-11425
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    January 30, 2024
    Report Date
    November 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATIONS : EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY. VOL. 65(2). HTTPS://DOI.ORG/10.1093/EJCTS/EZAE026.

    Description of Event or Problem · 0

    TITLE : SURGERY FOR TRACHEAL AND LARYNGOTRACHEAL STENOSIS: A HISTORICAL CASE SERIES. THE AIM OF THIS STUDY WAS TO INVESTIGATE OUTCOMES AFTER (LARYNGO-)TRACHEAL RESECTION¿ANASTOMOSIS, TO EXPLORE POTENTIAL RISK FACTORS FOR POSTOPERATIVE COMPLICATIONS AND TO ASSESS WHETHER, OVER A 33-YEAR PERIOD, THERE WERE MAJOR CHANGES IN SURGICAL INDICATIONS, TECHNIQUES OR OUTCOMES. THIS STUDY INCLUDES ALL CONSECUTIVE PATIENTS WHO UNDERWENT TRACHEAL OR LARYNGOTRACHEAL RESECTION AT THE THORACIC SURGERY UNIT OF PADUA UNIVERSITY HOSPITAL, FROM JANUARY 1990 TO MARCH 2023. OVER THE STUDY PERIOD, 211 PATIENTS UNDERWENT TRACHEAL OR LARYNGO-TRACHEAL RESECTION AT OUR CENTRE. THE MEMBRANOUS TRACHEA WAS SUTURED WITH A 4¿0 POLYDIOXANONE (PDS, ETHICON INC., SOMERVILLE, NJ, USA) SUTURE, WHILE THE ANTEROLATERAL ENDS WERE ANASTOMOSED WITH INTERRUPTED 3¿0 VICRYL SUTURES. ADDITIONALLY, 2 LATERAL 2¿0 VICRYL TRACTION SUTURES WERE PLACED PROXIMALLY AND DISTALLY FROM THE LINE OF RESECTION ON EACH SIDE. THE REPORTED COMPLICATIONS INCLUDED GLOTTIC OEDEMA (N=17), GRANULATIONS (N=12), RESTENOSIS (N=10), DEHISCENCE (N=9), VOCAL FOLD PARALYSIS (N=8), WOUND INFECTION (N=6), DYSPHAGIA (N=3), HEMATOMA (N=2), AND RESPIRATORY FAILURE (N=1). IN CONCLUSION, SURGICAL TREATMENT OF (LARYNGO-)TRACHEAL STENOSIS IS CHALLENGING AND SHOULD BE PERFORMED BY SPECIALIZED CENTRES. IN OUR EXPERIENCE, MORBIDITY AND MORTALITY RATES WERE SATISFACTORY, AND IN MOST CASES, PATIENTS COULD BREATHE WITHOUT TRACHEOSTOMY. THE LENGTH OF THE STENOSIS WAS THE MOST SIGNIFICANT RISK FACTOR FOR POSTOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177093 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention