BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7449843 · Received April 22, 2018

    Report

    Report Number
    2210968-2018-72249
    Event Type
    Injury
    Date Received
    April 22, 2018
    Report Date
    March 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CITATION: CHIN J LUNG CANCER. 2008; 11(5). DOI: 10.3779/J.ISSN.1009-3419.2008.05.021 - [(B)(4)- LUDWIG 2008.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: MORBIDITY AND MORTALITY AFTER NEOADJUVANT THERAPY AND SLEEVE LOBECTOMY IN N2-DISEASE¿ AUTHORS: CORINNA LUDWIG, WALBURGA ENGEL-RIEDEL, ERICH STOELBEN CITATION: CHIN J LUNG CANCER. 2008; 11(5). DOI: 10.3779/J.ISSN.1009-3419.2008.05.021. SLEEVE RESECTIONS WERE INTRODUCED TO PRESERVE LUNG FUNCTION IN PATIENTS WITH LIMITED PULMONARY RESERVE. INCREASING EXPERIENCE WITH SLEEVE RESECTION HAS REDUCED THE RATE OF PNEUMONECTOMY BELOW 10%. THE AIM OF THE STUDY WAS TO ASSESS THE OUTCOME AFTER NEOADJUVANT CHEMO- OR CHEMORADIOTHERAPY AND SLEEVE RESECTION IN PATIENTS WITH N2 NON-SMALL CELL LUNG CANCER. A TOTAL OF 41 PATIENTS (29 MEN AND 12 WOMEN; AGE RANGE: 46 TO 75 YEARS OLD) UNDERWENT PULMONARY ANATOMICAL RESECTIONS AND WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, A TENSION-FREE BRONCHIAL ANASTOMOSIS WAS PERFORMED WITH A CONTINUOUS PDS 4-0 SUTURE OVER THE COMPLETE CIRCUMFERENCE. SUTURE LINES WERE CHECKED FOR AIR LEAKS WITH AN AIRWAY PRESSURE OF 30 MMHG. REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC INSUFFICIENCY (N-4), POST-OPERATIVE BLEEDING (N-2) WHICH REQUIRED RE-INTERVENTION, TECHNICAL FAILURE OF THE ANASTOMOSIS (N-1) IN WHICH AN EARLY CORRECTION OF THE SUTURE WAS MADE, AND NECROSIS OF THE ANASTOMOSIS (N-1) WHICH REQUIRED RE INTERVENTION AND SECONDARY PNEUMONECTOMY. IT WAS CONCLUDED THAT SLEEVE RESECTION AFTER NEOADJUVANT THERAPY SHOULD BE PERFORMED WHENEVER POSSIBLE TO PRESERVE FUNCTIONING LUNG TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292516 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention