BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7045484 · Received November 20, 2017

    Report

    Report Number
    2210968-2017-71334
    Event Type
    Death
    Date Received
    November 20, 2017
    Date of Event
    January 1, 2013
    Report Date
    March 25, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 11/20/2017. CORRECTION D11: VICRYL PLUS SUTURE, GIA STAPLER.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE THAT PATIENT UNDERWENT LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB) ON UNKNOWN DATE BETWEEN 01/2009 AND 08/2012 AND SUTURE WAS USED. THE GASTROJEJUNAL ANASTOMOSIS WAS STAPLED AND REINFORCED BY INTERRUPTED HAND- SEWN ANTIBACTERIAL SUTURE. MESENTERIC DEFECTS WERE CLOSED USING NONABSORBABLE SUTURE MATERIAL. COMPLICATIONS: GASTROENTERIC LEAKAGE, WHICH MAY HAVE REQUIRED SURGICAL INTERVENTION AND STENTING AND/OR RE-DO OF STENOTIC ENTEROENTERAL ANALSTOMOSIS. POSSIBLE EXTRALUMINAL AND INTRALUMINAL SITES BLEEDING, WHICH MAY HAVE REQUIRED HEMATOMA EVACUATION, OVER SEWING, LAVAGE AND/ OR DRAINAGE. CONSERVATIVE MEASURES FOR BLEEDING MAY HAVE INCLUDED BLOOD TRANSFUSION. THE PATIENT MAY HAVE EXPERIENCED, ELEVATION OF INFLAMMATORY MARKERS, UPPER ABDOMINAL PAIN, TACHYCARDIA, AND/ OR WOUND DISCHARGE DUE TO WOUND INFECTION. ONE PATIENT DIED AFTER LRYGB DUE TO UNCONTROLLED SEPSIS FOLLOWING LEAKAGE. ADDITIONAL INFORMATION WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825681 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death