BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 7030114 · Received November 14, 2017

    Report

    Report Number
    2210968-2017-71242
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    October 18, 2013
    Report Date
    October 20, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    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. CITATION: J GASTROINTEST SURG (2013) 17:2051¿2058. DOI 10.1007/S11605-013-2382-3.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> PC-000061814 ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT VICRYL PLUS OR VICRYL SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, SPECIFICALLY: ANASTOMOTIC STRICTURE, ESOPHAGITIS, DYSPHAGIA, ANASTOMOTIC DILATION, ASYMPTOMATIC REFLUX? CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR THE SUBJECTS OF THIS ARTICLE? IF SO, PLEASE ALSO INCLUDE: PATIENT INITIALS, INITIAL PROCEDURE DATE, PRE-EXISTING CONDITIONS, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT. IS THE PRODUCT CODE AND LOT NUMBER AVAILABLE FOR ANY OF THE ETHICON DEVICES USED? NO FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE ¿CLINICAL APPLICATION OF MUCOSAL VALVE TECHNIQUE FOR ANASTOMOSIS DURING ESOPHAGOGASTROSTOMY¿ THAT SUTURE WAS USED IN A LAYER-TO-LAYER MUCOSAL VALVE TECHNIQUE DURING INTRATHORACIC ESOPHAGOGASTROSTOMY. THE STUDY COMPARED THE EFFICACY IN PREVENTION OF ANASTOMOTIC COMPLICATIONS USING LAYER-TO-LAYER MUCOSAL VALVE TECHNIQUE FOR ESOPHAGOGASTRIC INTRATHORACIC ANASTOMOSIS AFTER RESECTION FOR ESOPHAGEAL AND GASTRIC CARDIAC CARCINOMA. FOR LAYER-TO-LAYER VALVE ANASTOMOSIS, THE PROCEDURE INVOLVED STITCHING THE REAR MUCOSAL LAYERS WITH SUTURE IN EVERTED INTERRUPTED STITCHES TO ACHIEVE MUCOSA-TO-MUCOSA APPROXIMATION. OVERALL POSTOPERATIVE COMPLICATIONS IN THE LM GROUP WERE: DYSPHAGIA, ANASTOMOTIC STRICTURE, ANASTOMOTIC DILATION, ASYMPTOMATIC REFLUX, ESOPHAGITIS. DYSPHAGIA IS THE MOST FREQUENTLY MENTIONED SYMPTOMS ASSOCIATED WITH ANASTOMOTIC STRICTURE. ¿IN CONCLUSION, THE LAYERED MUCOSAL VALVE ESOPHAGOGASTRIC ANASTOMOSIS IS A SAFE AND EFFECTIVE ANASTOMOTIC TECHNIQUE, WHICH CAN SIGNIFICANTLY DIMINISH THE INCIDENCE OF ANASTOMOTIC COMPLICATIONS." ADDITIONAL INFORMATION WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807890 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention