BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7422328 · Received April 11, 2018

    Report

    Report Number
    2210968-2018-72085
    Event Type
    Injury
    Date Received
    April 11, 2018
    Report Date
    March 22, 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. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: SURG TODAY. 2015; 45: 1121 1126. DOI: 10.1007/S00595-014-1025-Y. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: EXTENDED SLEEVE LOBECTOMY AFTER INDUCTION CHEMORADIOTHERAPY FOR NON-SMALL CELL LUNG CANCER" AUTHORS: SHINICHI TOYOOKA, JUNICHI SOH, HIROMASA YAMAMOTO, MASAOMI YAMANE, SHIGERU HATTORI, KAZUHIKO SHIEN, KENTAROH MIYOSHI, SEIICHIRO SUGIMOTO, TAKAHIRO OTO, SHINICHIRO MIYOSHI CITATION: SURG TODAY. 2015; 45: 1121 1126. DOI: 10.1007/S00595-014-1025-Y EXTENDED SLEEVE LOBECTOMY IS A CHALLENGING SURGERY. WHILE INDUCTION CHEMORADIOTHERAPY (CHRT) FOLLOWED BY SURGERY IS ONE OF THE THERAPEUTIC STRATEGIES USED FOR LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC), CHRT CAN IMPAIR THE ANASTOMOTIC HEALING POTENTIAL. THE AUTHORS PRESENTED THEIR EXPERIENCE WITH CASES WHO UNDERWENT AN EXTENDED SLEEVE LOBECTOMY AFTER INDUCTION CHRT. A TOTAL OF 9 PATIENTS (7 MALES AND 2 FEMALES) UNDERWENT EXTENDED SLEEVE LOBECTOMIES AND WERE INCLUDED IN THE STUDY. DURING THE SURGICAL PROCEDURE, A COMPLETE LYMPH NODE DISSECTION OF THE IPSILATERAL SUPERIOR MEDIASTINUM AND SUBCARINA WAS ROUTINELY PERFORMED. A BRONCHIAL ANASTOMOSIS WAS PERFORMED WITH RUNNING SUTURES USING PDS II 4-0 FOR THE BOTTOM PORTION OF THE ANASTOMOSIS. INTERRUPTED SUTURES USING PDS II 4-0 SUTURES WERE PLACED ON THE OTHER PORTION. THE BRONCHIAL SUTURE LINE WAS WRAPPED WITH A PERICARDIAL FAT PAD OR OMENTAL PEDICLED FLAP WITH PROPHYLACTIC INTENT. REPORTED COMPLICATIONS INCLUDED A (B)(6) MALE PATIENT (CASE 1) WITH A BRONCHOPLEURAL FISTULA ON POST-OPERATIVE DAY 25 AND REQUIRED A COMPLETION PNEUMONECTOMY. IT WAS REPORTED THAT THE ANASTOMOSIS OF THE SPARED LUNG TO THE PROXIMAL BRONCHUS IS ONE OF THE CRITICAL POINTS OF AN EXTENDED SLEEVE LOBECTOMY. IT WAS CONCLUDED THAT AN EXTENDED SLEEVE LOBECTOMY AFTER INDUCTION CHRT IS FEASIBLE, BUT CAREFUL PATIENT SELECTION AND PERIOPERATIVE MANAGEMENT ARE MANDATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265711 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention