BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 10764289 · Received October 30, 2020

    Report

    Report Number
    2210968-2020-08499
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    December 3, 2018
    Report Date
    October 9, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    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 SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: INTERNATIONAL JOURNAL OF UROLOGY (2019) 26, 363-368; DOI: 10.1111/IJU.13873.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE, 'TITLE: EN BLOC LAPAROSCOPIC RADICAL NEPHRECTOMY WITH INFERIOR VENA CAVA THROMBECTOMY: A SINGLE-INSTITUTION EXPERIENCE'. AUTHORS: YOICHIRO TOHI, NORIYUKI MAKITA, ISSEI SUZUKI, RYOSUKE SUZUKI, MASASHI KUBOTA, YOSHIO SUGINO, KOJI INOUE AND MUTSUSHI KAWAKITA CITATION: INTERNATIONAL JOURNAL OF UROLOGY (2019) 26, 363-368; DOI: 10.1111/IJU.13873. THE OBJECTIVE OF THIS RETROSPECTIVE REVIEW WAS TO REPORT THE OUTCOMES OF LAPAROSCOPIC RADICAL NEPHRECTOMY WITH INFERIOR VENA CAVA THROMBECTOMY (LRN-VCT) FOR RIGHT RENAL CELL CARCINOMA (RCC) AT KOBE CITY MEDICAL CENTER GENERAL HOSPITAL, KOBE, HYOGO, JAPAN. FIVE PATIENTS INCLUDED IN THE STUDY UNDERWENT LRN-VCT FOR RIGHT RCC BETWEEN 2013 AND 2017 AT KOBE CITY MEDICAL CENTER GENERAL HOSPITAL. THE MEDIAN FOLLOW-UP PERIOD WAS 19.8 MONTHS (RANGE 3.6¿47.8 MONTHS). THE PATIENTS¿ DETAILS WERE AS FOLLOWS: CASE 1- 80Y/O FEMALE, CASE 2- 68 Y/O MALE, CASE 3- 54 Y/O MALE, CASE 4- 45 Y/O MALE, AND CASE 5- 68 Y/O MALE. FOR THE PROCEDURE, THE INFERIOR VENA CAVA INCISION WAS LAPAROSCOPICALLY CLOSED WITH A CONTINUOUS 5-0 PROLENE SUTURE (ETHICON, SOMERVILLE, NJ, USA). A MAJOR COMPLICATION WAS NOTED IN CASE 1 PATIENT (CLAVIEN¿DINDO GRADE =3), WHICH WAS POSTOPERATIVE INTRAPERITONEAL HEMORRHAGE REQUIRING TRANSARTERIAL EMBOLIZATION. IN CONCLUSION, THE AUTHORS REPORTED THAT LRN-VCT IS A CHALLENGING YET FEASIBLE PROCEDURE FOR EXPERIENCED SURGEONS IN CAREFULLY SELECTED PATIENTS. FURTHER STUDIES OF THIS SURGICAL PROCEDURE ARE REQUIRED FOR STANDARDIZATION AND SAFE APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226835 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention