BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 7668721 · Received July 8, 2018

    Report

    Report Number
    2210968-2018-74168
    Event Type
    Injury
    Date Received
    July 8, 2018
    Report Date
    June 18, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    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. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: EMERGENT COMPLETION PNEUMONECTOMY FOR POSTOPERATIVE HEMORRHAGE FROM RUPTURE OF THE INFECTED PULMONARY ARTERY IN LUNG CANCER SURGERY. AUTHOR: TAKANORI AYABE, TETSUYA SHIMIZU, MASAKI TOMITA, MITSUHIRO YANO, KUNIHIDE NAKAMURA, AND TOSHIO ONITSUKA. CITATION: HINDAWI PUBLISHING CORPORATION CASE REPORTS IN SURGERY VOLUME 2011, ARTICLE ID 902062, 4 PAGES; DOI:10.1155/2011/902062 . THIS CASE STUDY IS ABOUT A (B)(6)-YEAR-OLD MALE WITH AN ABNORMAL SHADOW IN THE LEFT UPPER FIELD IN THE CHEST X-RAY FILM WAS DIAGNOSED WITH ADENOCARCINOMA OF LUNG CANCER BY BRONCHOSCOPIC EXAMINATION (CT3N0M0, C-STAGE IIA). ON THE 6TH POSTOPERATIVE DAY (POD), A SUDDEN INTRATHORACIC HEMORRHAGE WITH SHOCK HAD BEEN OCCURRED. EMERGENT REDO THORACOTOMY WAS PERFORMED TO TREAT THE EXCESSIVE INTRATHORACIC BLEEDING VIA THE SAME OPERATIVE INCISION. THE HEMORRHAGE WAS FOUND FROM THE EXFOLIATED FRAGILE LESION OF INTERLOBAR PULMONARY ARTERY, WHICH WAS CLOSED WITH 5¿0 PROLENE SUTURE WITH PLEDGETS. A LARGE AMOUNT OF INTRATHORACIC HEMATOMA HAD BEEN REMOVED. AFTER THE SURGERY, A CONTINUOUS AIR LEAK WITH SPIKED FEVER HAD BEEN CONTINUED UNTIL THE 9TH POD. THE LEVEL OF C-REACTIVE PROTEIN WAS 28.6 MG/DL. AT 19:50 ON THE 10TH POD, SUDDEN EXCESSIVE HEMORRHAGE (1500 ML) WAS OCCURRED THROUGH THORACIC DRAINAGE TUBE WITH SHOCK. BY PUMPING TRANSFUSION OF RED CELL CONCENTRATES, THE PATIENT WAS MOVED TO OPERATING ROOM; EMERGENT SALVAGE SURGERY WAS PERFORMED. THE COMPLETELY SUTURED LESION FOR THE FIRST BLEEDING DISPLAYED NO ABNORMALITY; HOWEVER, THE SECOND HEMORRHAGE OCCURRED IN A DIFFERENT LESION, PROXIMAL PULMONARY ARTERY, AND WHICH RESULTED IN A RUPTURE DUE TO INFECTION. THE OPENED CHEST WALL WOUND WAS CLOSED ON THE 110TH POD. THE SKIN WOUND HAD BEEN CLOSED AND HE HAD BEEN DISCHARGED ON THE 141TH POD. HE HAS BEEN ALIVE WITH NO RECURRENCE FOR SEVEN YEARS. NO FURTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510822 PROLENE POLYPROPYLENE SUTURE SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR