BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 4936471 · Received July 23, 2015

    Report

    Report Number
    3003701944-2015-00605
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    July 8, 2015
    Report Date
    September 15, 2015
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. DURING INNER ILLUMINATION THE SHUNTS' LUMEN WAS FOUND TO BE BLOCKED. AFTER CLEANING THE SHUNT, THE LUMEN REMAINED BLOCKED. AFTER SLICING THE SHUNT LUMEN OPENINGS WERE SEEN ON BOTH SIDES OF THE RESTRICTION UNIT AND NO WELDING PENETRATION WERE FOUND. THEREFORE, THERE IS NO INDICATION OF MANUFACTURING RELATED FACTORS THAT COULD CAUSE THE BLOCKAGE. DURING PRODUCTION, 100% FINAL INSPECTION IS BEING PERFORMED ON THE ENTIRE BATCH, INCLUDING INNER ILLUMINATION. IF SUCH A DEFECT HAD BEEN NOTICED DURING THE INSPECTION, THE PRODUCT WOULD HAVE BEEN REJECTED IMMEDIATELY. HAVING SAID THAT, ONE MAY CONCLUDE, THAT THE BLOCKAGE WAS FORMED AFTER THE PRODUCT HAD LEFT THE MANUFACTURING PLANT. THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED SINCE THE BLOCKAGE COULD HAVE BEEN CAUSED BY MANY DIFFERENT REASONS DURING AND AFTER THE CLINICAL PROCEDURE. THE BLOCKAGE DOES NOT SEEM TO BE PRODUCT RELATED SINCE THE RESTRICTION UNIT WAS SEEN TO BE CENTERED AND AFTER CLEANING THE DEVICE NO LIGHT OBSTRUCTIONS WERE SEEN. THEREFORE, THERE IS NO EVIDENCE FOR AN INHERENT DEFECT THAT MIGHT HAVE CAUSED THE EVENT, AND THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT A FILTERING BLEB REVISION WAS PERFORMED FOUR MONTHS FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) PROCEDURE AFTER THE GFD BLOCKAGE WAS CONFIRMED. THERE WAS NO FLOW OF AQUEOUS HUMOR CONFIRMED WHEN THE SCLERAL FLAP WAS INCISED AND THUS TRABECULECTOMY WAS PERFORMED UNDER THE SAME SCLERAL FLAP. THE GFD WAS REMOVED AND THE SURROUNDING TISSUE WAS ALSO REMOVED DUE TO THE BLOCKAGE. THE POSTOPERATIVE PROCEDURES (NEEDLING ETC.) HAD NOT BEEN PERFORMED BECAUSE THIS PATIENT FELT A PAIN. THE PAIN WAS CAUSED BY THE NEEDLING. THE SURGEON THOUGHT THAT BLOCKAGE OF THE SHUNT MIGHT NOT OCCUR IF ENOUGH FLOW WAS ABLE TO BE KEPT FROM RIGHT AFTER THE SURGERY. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479405 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R