BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISTENT INJECT W TRABECULAR MICRO-BYPASS SYSTEM

    MDR report key: 9582576 · Received January 13, 2020

    Report

    Report Number
    2032546-2020-00009
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 1, 2019
    Report Date
    February 5, 2020
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MFR# REFERENCE: (B)(4). H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. DURING POSTOPERATIVE EXAMINATION, THE STENT APPEARED PLACED "TOO LOW UNDER THE SCLERAL SPUR (LEADING TO THE SUPRACILIARY SPACE). THERE WAS NO ADVERSE IMPACT AND THE PATIENT WAS BEING MONITORED.

    Additional Manufacturer Narrative · 1

    ESTIMATED DATE USED BASED ON THE INFORMATION REPORTED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION; THEREFORE TESTING ON THE ACTUAL DEVICE COULD NOT BE PERFORMED. THE DEVICE IDENTIFIERS WERE NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS FOR THIS DEVICE LOT NUMBER COULD NOT BE REVIEWED. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. IMPLANT MALPOSITION IS IDENTIFIED IN THE LABELING AS A KNOWN INHERENT RISK OF TRABECULAR MICRO-BYPASS STENT SURGERY. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THIS DEVICE IS NOT CURRENTLY APPROVED FOR MARKETING IN THE US, BUT WAS REPORTED BASED ON SIMILARITY WITH THE APPROVED DEVICE MODEL G2-M-IS (PMA# P170043). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE (1) OF THE TWO (2) STENTS FROM THE TRABECULAR MICRO BYPASS SYSTEM WAS INADVERTENTLY IMPLANTED IN THE SUPRACILIARY SPACE, SLIGHTLY POSTERIOR TO THE TRABECULAR MESHWORK (TM) DURING THE PROCEDURE. REPORTEDLY, THE SURGEON EXPERIENCED INTRAOPERATIVE VISUALIZATION ISSUES. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44268 ISTENT INJECT W TRABECULAR MICRO-BYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION G2-W

    Patients

    Seq Age Sex Outcome Treatment
    1