BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM

    MDR report key: 9712758 · Received February 14, 2020

    Report

    Report Number
    2032546-2020-00018
    Event Type
    Injury
    Date Received
    February 14, 2020
    Date of Event
    January 27, 2020
    Report Date
    March 20, 2020
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P170043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD REVIEW OF THE MANUFACTURING LOT WAS PERFORMED AND THERE WERE NON-CONFORMITIES FOUND TO BE RELATED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. INFLAMMATION 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 · 0

    THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. REPORTEDLY, THE PATIENT UNDERWENT AN UNEVENTFUL RIGHT EYE CATARACT PLUS STENT PROCEDURE. PER REPORT, THE PATIENT WAS NOT ON ANTICOAGULANT AT ANY TIME, AND THE HYPHEMA OCCURRED RIGHT AFTER STENT IMPLANTATION. THE HYPHEMA WAS CHARACTERIZED AS GRADE III (>1/2 ANTERIOR CHAMBER VOL.) AND RESULTED IN INFLAMMATION/IRRITATION WHICH REQUIRED LONGER COURSE OF TOPICAL STEROIDS (CYCLOSPORINE). PER REPORT, THE PATIENT WAS STILL ON TWO (2) IOP MEDICATIONS AND THE SURGEON MAYBE ABLE TO ELIMINATE ONE OF THE IOP MEDICATIONS. THE MOST RECENT PROGNOSIS WAS REPORTED AS ¿ADVERSE EVENT ALMOST RESOLVED¿ WITH A FOLLOW-UP SCHEDULED.

    Additional Manufacturer Narrative · 1

    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. HYPHEMA AND DECREASED/IMPAIRED VISION ARE IDENTIFIED IN THE LABELING AS KNOWN INHERENT RISKS OF TRABECULAR MICRO-BYPASS STENT PROCEDURE. AN ADVERSE EVENT APPEARS TO HAVE OCCURRED, BUT DOES NOT APPEAR TO HAVE BEEN A PROBLEM WITH THE DEVICE OR THE WAY IT WAS USED. HYPHEMA AND DECREASED/IMPAIRED VISION ARE ESTABLISHED RISKS ASSOCIATED WITH USE OF THE DEVICE, WHICH IS CLEARLY SPECIFIED IN THE PRODUCT'S LABELING. 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

    IT WAS REPORTED THAT FOLLOWING A CATARACT PLUS TRABECULAR MICRO BYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED ON POSTOP DAY ONE (1) WITH HYPHEMA ASSOCIATED WITH HAND MOTION VISION. THE SURGEON CONFERRED WITH GLAUKOS MEDICAL MONITOR WHO REPORTED THAT THE PATIENT IS ON THE RIGHT TRACK AND WILL TREAT THE HYPHEMA ACCORDINGLY. IN ADDITION, WAYS TO PREVENT SIMILAR REPORTED EVENT AND TREATMENT OPTIONS FOR THE REPORTED EVENT WERE DISCUSSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173487 ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION G2-M-IS 127150

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other