BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7355582 · Received March 20, 2018

    Report

    Report Number
    2210968-2018-71546
    Event Type
    Injury
    Date Received
    March 20, 2018
    Report Date
    March 1, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: UPDATES SURG. 2017 DEC 1. DOI: 10.1007/S13304-017-0502-4.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT IS NOT REPORTABLE.

    Description of Event or Problem · 1

    TITLE: BARBED VERSUS TRADITIONAL SUTURE FOR ENTEROTOMY CLOSURE AFTER LAPAROSCOPIC RIGHT COLECTOMY WITH INTRACORPOREAL MECHANICAL ANASTOMOSIS: A CASE¿CONTROL STUDY THE STUDY AIMED TO ESTABLISH THE SAFETY AND EFFICACY OF BARBED SUTURE FOR ENTEROTOMY CLOSURE AFTER LAPAROSCOPIC RIGHT COLECTOMY FOR CANCER WITH INTRACORPOREAL MECHANICAL ANASTOMOSIS. FROM (B)(6)2009 TO (B)(6)2015, 94 PATIENTS UNDERWENT LAPAROSCOPIC RIGHT HEMICOLECTOMY WITH INTRACORPOREAL MECHANICAL ANASTOMOSIS AND PATIENTS WERE DIVIDED INTO TWO GROUPS FOR ENTEROTOMY CLOSURE: BARBED SUTURE CLOSURE ¿ BRB GROUP (N=47; N=20 MALE, 27 FEMALE; MEAN AGE OF 72.5 YEARS) WHERE V-LOC WAS UTILIZED, AND CONVENTIONAL SUTURE CLOSURE ¿ CSC GROUP (N=47, N=25 MALE, N=22 FEMALE; MEAN AGE OF 69 YEARS) WHERE 3/0 VICRYL (POLYGLACTIN) SUTURES WAS USED. IN THE CSC GROUP, THE ENTEROTOMIES WERE THEN CLOSED USING A DOUBLE LAYERED FULL-THICKNESS CONTINUOUS INTRA CORPOREAL MANUAL SUTURE USING 3/0 VICRYL (POLYGLACTIN) SUTURES. IN CSC GROUP, COMPLICATIONS INCLUDED SURGICAL SITE INFECTIONS (N=4), ANASTOMOTIC LEAK/DEHISCENCE (N=1) FOR WHICH PATIENT HAD REOPERATION, WOUND INFECTIONS (N=2), AND INTERNAL HERNIA (N=1) WITH A SMALL BOWEL OCCLUSION THAT REQUIRED RE-INTERVENTION AND ONE EXTRACTION SITE HERNIA. CLOSING ENTEROTOMIES IN LAPAROSCOPIC PROCEDURES HAVE ALWAYS BEEN CHALLENGING, AND FURTHERMORE, ITS COMPLICATIONS ARE RESPONSIBLE FOR A LARGE PROPORTION OF THE ENSUING MORTALITY AND MORBIDITY (LEAKS, FISTULA, INTRAABDOMINAL ABSCESS, AND STENOSIS) AND MAY HAVE A NEGATIVE IMPACT ON THE LONG-TERM PROGNOSIS OF PATIENTS UNDERGOING SURGERY FOR DIGESTIVE CANCER. ADDITIONAL INFORMATION WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195507 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention