BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9335145 · Received November 18, 2019

    Report

    Report Number
    2210968-2019-90029
    Event Type
    Injury
    Date Received
    November 18, 2019
    Report Date
    October 29, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE THIS MEDWATCH 2210968-2019-90029 IS NOT REPORTABLE. AFTER DETAILED REVIEW OF JOURNAL ARTICLE, VICRYL SUTURE WAS USED AS A SECONDARY STAPLE LINE REINFORCEMENT AND NO LEAK FROM PATIENTS WITH VICRYL SUTURE WERE REPORTED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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 PATIENT 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON (VICRYL) SUTURE PRODUCTS USED IN THIS PROCEDURE? CITATION: OBES SURG (2016) 26:1782¿1787 / DOI 10.1007/S11695-015-2003-1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: IMPACT OF THE SURGICAL EXPERIENCE ON LEAK RATE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY" AUTHOR(S): PATRICK NOEL & MARIUS NEDELCU & MICHEL GAGNER CITATION: OBES SURG (2016) 26:1782¿1787 / DOI 10.1007/S11695-015-2003-1. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO ANALYZE THE CORRELATION BETWEEN THE SURGEON¿S EXPERIENCE AND THE LEAK RATE AFTER LSG. BETWEEN SEP 2005 AND DEC 2014, A TOTAL OF 2012 LSG CASES WERE PERFORMED. THE GREATER CURVATURE OF THE STOMACH WAS FREED, STARTING FROM THE MIDDLE OF THE STOMACH, WITH A SEALING DEVICE: THE HARMONIC SCALPEL (ULTRACISION, ETHICON) FOR GROUP A (N=1000) AND THE ULTRASONIC BIPOLAR DISSECT OR (THUNDERBEAT) FOR GROUP B (N=1012). REINFORCEMENT BY SEROMUSCULAR SUTURING WAS NOT USED FOR THE FIRST 1200 CASES. IN THE LAST 800 CASES, GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT WAS USED. IN ALL CASES, HEMOSTASIS OF THE STAPLE LINE WAS DONE BY BIPOLAR GRASP, AND IN 378 PATIENTS, AN ADDITIONAL VICRYL 3.0 STITCH WAS USED BETWEEN THE STAPLE LINES. POSTOPERATIVE COMPLICATIONS INCLUDED HEMATOMA (N=22, N=20 GROUP A, N=2 GROUP B), STENOSIS (N=2), GASTRIC LEAK (N=20, N=18 GROUP A, N=2 GROUP B), INFARCTUS (N=1) AND SEPSIS (N=1). LSG CAN BE PERFORMED WITH A LOW COMPLICATION RATE. THIS LARGE SERIES OF A SINGLE SURGEON¿S EXPERIENCE DEMONSTRATED THAT THE LEAK RATE AFTER LSG COULD BE SIGNIFICANTLY DECREASED OVER TIME WITH CHANGES IN TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133612 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention