BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20549587 · Received October 28, 2024

    Report

    Report Number
    2210968-2024-11181
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    December 6, 2023
    Report Date
    October 28, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    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 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. CITATION: THORAC CARDIOVASC SURG 2024;72:242¿249. DOI HTTPS://DOI.ORG/10.1055/A-2199-2164.

    Description of Event or Problem · 0

    TITLE: PNEUMONECTOMY WITH CARINAL SLEEVE RESECTION IN PATIENTS WITH NON-SMALL-CELL LUNG CANCER THE AIM OF THIS STUDY WAS TO EVALUATE THE MORBIDITY AND LONG-TERM SURVIVAL OF PATIENTS WITH NON-SMALL-CELL LUNG CANCER (NSCLC) WHO UNDERWENT SLEEVE PNEUMONECTOMY, EITHER FOR CURATIVE INTENT OR AS AN OPTION TO TREAT POSTOPERATIVE COMPLICATIONS. A TOTAL OF 50 PATIENTS (13 FEMALES AND 37 MALES) WITH NSCLC WHO UNDERWENT PNEUMONECTOMY WITH CARINA SLEEVE RESECTION WERE INCLUDED IN THE STUDY. THE MEAN AGE WAS 61.6 YEARS (RANGE: 44¿77 YEARS), THE MEAN BODY MASS INDEX (BMI) WAS 25.2 (RANGE: 18¿34), AND THE MEAN DURATION OF HOSPITALIZATION WAS 16.2 DAYS (RANGE: 7¿38 DAYS). THIRTY-ONE CASES FOR CURATIVE TREATMENT OF NSCLC (PRIMARY SLEEVE PNEUMONECTOMY [PSP]) AND 19 PATIENTS WERE TREATED BECAUSE OF POSTPNEUMONECTOMY BRONCHIAL STUMP INSUFFICIENCY OR BRONCHIAL ANASTOMOSIS DEHISCENCE (SECONDARY SLEEVE PNEUMONECTOMY [SSP]). THE PARIES MEMBRANACEUS WAS SUTURED BY SINGLE RUNNING SUTURE WITH POLYDIOXANONE SUTURE (PDS) 4¿0; AFTERWARD, THE SIDES AND THE VENTRAL SECTIONS WERE SUTURED IN INTERRUPTED TECHNIQUE WITH PDS 3¿0. KNOTS WERE PLACED EXTRALUMINALLY. THE MEAN FOLLOW-UP WAS 29.78 MONTHS (RANGE: 0¿60 MONTHS). REPORTED COMPLICATIONS INCLUDE PNEUMONIA (N=9), PLEURAL EMPYEMA (N=5), SEPSIS (N=5), RESPIRATORY INSUFFICIENCY (N=6), PROLONGED AIR LEAKAGE (N=3), PROLONGED HEALING OF BRONCHIAL ANASTOMOSIS (N=1), AND HEMOTHORAX (N=1). IN CONCLUSION, CARINAL SLEEVE RESECTION WITH PNEUMONECTOMY IS A FEASIBLE PROCEDURE WITH LIMITED MORBIDITY AND MORTALITY. THIS PROCEDURE IS A REASONABLE THERAPEUTIC OPTION FOR PATIENTS WITH LOCALLY ADVANCED CENTRAL NSCLC AFTER MANDATORY PATIENT SELECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321632 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other