BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 10764210 · Received October 30, 2020

    Report

    Report Number
    2210968-2020-08497
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    February 11, 2019
    Report Date
    October 9, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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 ETHICON PRODUCTS (PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (BRONCHIAL ANASTOMOTIC STENOSIS, ATELECTASIS, SUBCUTANEOUS EMPHYSEMA, PROLONGED AIR LEAK, PNEUMONIA AND PULMONARY EMBOLISM) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: ANN THORAC SURG 2019;108:211¿8. DOI: HTTPS://DOI.ORG/10.1016/J.ATHORACSUR.2019.02.028.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: ROBOTIC BRONCHIAL SLEEVE LOBECTOMY FOR CENTRAL LUNG TUMORS: TECHNIQUE AND OUTCOME". AUTHOR: WENJIE JIAO, MD, PHD, YANDONG ZHAO, MD, TONG QIU, MD,YUNPENG XUAN, MD,XIAO SUN, MD, YI QIN, MD, AO LIU, MD, TIANYI SUI, MD, AND JIAN CUI, MD. CITATION: ANN THORAC SURG 2019;108:211¿8. DOI: HTTPS://DOI.ORG/10.1016/J.ATHORACSUR.2019.02.028. THIS RETROSPECTIVE STUDY MAINLY FOCUSES ON THE TECHNIQUES OF ROBOTIC BRONCHIAL SLEEVE LOBECTOMY, ESPECIALLY BRONCHIAL ANASTOMOSIS, AND POSTOPERATIVE OUTCOMES. BETWEEN OCTOBER 2014 AND MARCH 2018, 67 PATIENTS (AGE, 54.6+21.5 YEARS, MALE N=55 AND FEMALE N=12) WHO UNDERWENT ROBOTIC BRONCHIAL SLEEVE LOBECTOMY. BRONCHIAL ANASTOMOSIS BETWEEN THE PROXIMAL MAIN BRONCHUS AND THE DISTAL LOBAR WAS APPLIED WITH HALF CONTINUOUS SUTURE TECHNIQUE WITH THE USE OF TWO 3/0 PROLENE SUTURES (ETHICON). A SEALING TEST WAS PERFORMED TO CONFIRM THERE WAS NO LEAKAGE AFTER COMPLETION OF THE ANASTOMOSIS. THE FOLLOWING POST-OPERATIVE COMPLICATIONS WERE REPORTED: BRONCHIAL ANASTOMOTIC STENOSIS (N=1), ATELECTASIS (N=1), SUBCUTANEOUS EMPHYSEMA (N=2),PROLONGED AIR LEAK > 7 DAYS (N=2), PNEUMONIA (N=1) AND PULMONARY EMBOLISM (N=1). BRONCHIAL STENOSIS REQUIRED ENDOTRACHEAL INTERVENTIONAL LASER ABLATION AND THE CASES OF ATELECTASIS REQUIRED BRONCHOSCOPY. ROBOTIC BRONCHIAL SLEEVE LOBECTOMY AND THE NOVEL ANASTOMOTIC TECHNIQUE ARE BOTH FEASIBLE AND SAFE FOR CAREFULLY SELECTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229781 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention