BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 11296349 · Received February 8, 2021

    Report

    Report Number
    2210968-2021-01116
    Event Type
    Injury
    Date Received
    February 8, 2021
    Date of Event
    December 16, 2020
    Report Date
    January 11, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    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. 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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (MERSILENE SUTURE 5-0) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (CONJUNCTIVAL EROSION, HYPOTONY) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (MERSILENE SUTURE 5-0) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS ABOVE. CITATION: RETINA 40:303¿311, 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: ADVERSE EVENTS OF THE ARGUS II RETINAL PROSTHESIS INCIDENCE, CAUSES, AND BEST PRACTICES FOR MANAGING AND PREVENTING CONJUNCTIVAL EROSION". AUTHOR: STANISLAO RIZZO,MD, PIERRE-OLIVIER BARALE, MD, SARAH AYELLO-SCHEER, MD, ROBERT G. DEVENYI, MD, MARIE-NOËLLE DELYFER, MD, PHD, JEAN-FRANÇOIS KOROBELNIK, MD, ALEKSANDRA RACHITSKAYA, MD, ALEX YUAN, MD, PHD, K. THIRAN JAYASUNDERA, MD, DAVID N. ZACKS, MD, PHD, JAMES T. HANDA, MD, SANDRA R. MONTEZUMA, MD, DARA KOOZEKANANI, MD, PHD, PAULO E. STANGA, MD, LYNDON DA CRUZ, MD,PHD, PETER WALTER, MD, ALBERT J. AUGUSTIN, MD, MARZIO CHIZZOLINI, MD, LISA C. OLMOS DE KOO, MD, MBA, ALLEN C. HO, MD, BERND KIRCHHOF, MD, PAUL HAHN, MD, PDH, LEJLA CAJZOVIC, MD, RAYMOND IEZZI, JR., MD, DAVID GAUCHER, MD, PHD, J. FERNANDO AREVALO, MD, NINEL Z. GREGORI, MD, SALVATORE GRISANTI, MD, EMIN ÖZMERT, MD, YOUNG HEE YOON, MD, PHD, GREGG T. KOKAME, MD, JENNIFER I. LIM, MD, PETER SZURMAN, MD, EUGENE DE JUAN, JR., MD, FLAVIO A. REZENDE, MD, PHD, JOËL SALZMANN, MD, GISBERT RICHARD, MD, SUBER S. HUANG, MD, MBA, FRANCESCO MERLINI, MSC, UDAY PATEL, PHD, CYNTHIA CRUZ, MSC, ROBERT J. GREENBERG, MD, PHD, SALLY JUSTUS, MD, LAURA CINELLI, MD, MARK S. HUMAYUN, MD, PHD. CITATION: RETINA 40:303¿311, 2020. DOI: NOT REPORTED. THIS RETROSPECTIVE ANALYSIS AIMS TO ANALYZE AND PROVIDE AN OVERVIEW OF THE INCIDENCE, MANAGEMENT, AND PREVENTION OF CONJUNCTIVAL EROSION IN ARGUS II CLINICAL TRIAL SUBJECTS AND POST APPROVAL PATIENTS. BETWEEN JUNE 2007 AND NOVEMBER 2017, 274 PATIENTS (30 FROM UNITED STATES AND EUROPE ENROLLED IN MULTICENTER FEASIBILITY STUDY AND 244 WERE FROM THE POST APPROVAL PHASE) HAD ARGUS II DEVICE IMPLANT PROCEDURES. IN SUTURING IMPLANT TABS, 5-0 MERSILENE (ETHICON) WAS USED RATHER THAN 5-0 NYLON (ETHICON). POSTOPERATIVELY, CONJUNCTIVAL EROSION (N=3.6%) AND HYPOTONY (N=UNKNOWN) WAS REPORTED. IN THE CASE THAT THE ELECTRODE CABLE MAY RUB AGAINST THE CONJUNCTIVA AND INDUCE EROSION, THE FIRST DEMAND IS TO ADDRESS THE HYPOTONY THEN FLATTENING THE ELECTRODE CABLE WITH 6-0 MERSILENE SUTURE (ETHICON) MATERIAL AND BILAYER PATCH WITH AN AUTOLOGOUS TISSUE. REDUCING OCCURRENCE OF CONJUNCTIVAL EROSION IN PATIENTS WITH THE ARGUS II RETINAL PROSTHESIS REQUIRES IDENTIFICATION AND MINIMIZATION OF RISK FACTORS BEFORE AND DURING IMPLANTATION. IMPLEMENTING INVERTED SUTURES AT THE IMPLANT TABS, USE OF GRAFT MATERIAL AT THESE LOCATIONS AS WELL AS MERSILENE (ETHICON) RATHER THAN NYLON SUTURES, AND ACCURATE TENON¿S AND CONJUNCTIVA CLOSURE ARE RECOMMENDED FOR CONSIDERATION IN ALL PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191296 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention