BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM

    MDR report key: 8466714 · Received March 29, 2019

    Report

    Report Number
    2032546-2019-00043
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 8, 2019
    Report Date
    July 3, 2019
    Product Code
    OGO
    PMA / PMN Number
    P170043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE STENT REMAINS IN THE PATIENT'S EYE; THEREFORE, THE SURGERY DATE WAS INDICATED IN THE IMPLANT DATE FIELD. CORRECTION: E1 (NAME). THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO NON-CONFORMITIES FOUND TO BE RELATED TO THE REPORTED EVENT . MFR# REFERENCE: (B)(4).

    Description of Event or Problem · 0

    THROUGH FOLLOW-UP, THE SURGEON REPORTED THAT THE PATIENT UNDERWENT UNEVENTFUL LEFT EYE CATARACT PLUS STENT PROCEDURE. POSTOPERATIVELY, THE SURGEON WAS ABLE VISUALIZED ONE (1) STENT IN TRABECULAR MESHWORK (TM) AND SECOND STENT EXTRUDED, SEATING ON IRIS IN NASAL ANGLE. THE SURGEON NOTED THAT THE STENT WAS PRESENT DURING THE MOST RECENT GONIO EXAMINATION. ACCORDING TO THE SURGEON, THE STENT POSITIONING DID NOT RESULT IN ANY ADVERSE IMPACT TO THE PATIENT AND THE PATIENT WAS BEING MONITORED. THE SURGEON DOES NOT PLAN TO INTERVENE, AND THE PATIENT¿S PROGNOSIS WAS REPORTED AS ¿GOOD¿.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE; THEREFORE, PRODUCT TESTING ON THE ACTUAL DEVICE COULD NOT BE PERFORMED. THE DEVICE IDENTIFIERS WERE NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY RECORDS FOR THIS DEVICE LOT NUMBER COULD NOT BE REVIEWED. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. DISLODGED STENT IS IDENTIFIED IN THE LABELING AS A KNOWN INHERENT RISK OF TRABECULAR MICRO-BYPASS STENT PROCEDURE. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. MFR # REFERENCE: (B)(4).

    Description of Event or Problem · 1

    INITIALLY, IT WAS REPORTED THAT FOLLOWING CATARACT PLUS TRABECULAR MICRO BYPASS STENT SYSTEM, THE PATIENT PRESENTED ON POST-OP WEEK ONE (1) WITH ONE (1) OF THE TWO (2) STENTS DISLODGED AND FLOATING IN THE ANGLE. FOLLOWING MEDICAL CONSULT, THE SURGEON REPORTED THAT THE STENT WAS NOT FREELY MOBILE. IT IS NESTLED IN THE NASAL ANGLE AT 3 OR 4 O'CLOCK. TREATMENTS OPTIONS WERE DISCUSSED DEPENDING ON PATIENT STATUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256494 ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO G2-M-IS 118298

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR