BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM

    MDR report key: 16988872 · Received May 23, 2023

    Report

    Report Number
    2032546-2023-00054
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 10, 2023
    Report Date
    June 29, 2023
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P170043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MFR# REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: 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 FOR THIS DEVICE LOT NUMBER COULD NOT BE REVIEWED. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. DISLODGED/DISLOCATED 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. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY IDENTIFIED. MFR# REFERENCE: (B)(4).

    Description of Event or Problem · 0

    THROUGH FOLLOW-UP, THE SURGEON CONFERRED WITH EXPERT OPINION MD WHO REPORTED DISCUSSING FURTHER TREATMENT OPTIONS BASED ON THE PATIENT''S CONDITION AND THE STENT''S POSITIONING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED ONE (1) WEEK POSTOP WITH A DISLODGED STENT DESCRIBED AS "LOOSE AND SITTING ON IRIS". THERE WAS NO REPORT OF PATIENT INJURY OR INTERVENTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463128 ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION G2-W-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other