BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM

    MDR report key: 8002840 · Received October 24, 2018

    Report

    Report Number
    2032546-2018-00108
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    October 4, 2018
    Report Date
    October 21, 2018
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P170043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MFR REFERENCE# (B)(4).

    Description of Event or Problem · 0

    THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. REPORTEDLY, THERE WAS MINOR INTRAOPERATIVE BLEEDING AS THE STENT ENGAGED THE IRIS (1 MM ON IRIS) UPON INSERTION. POSTOPERATIVELY, VITREOUS HEMORRHAGE WAS ASSOCIATED WITH BCVA LOSS AND HAZY VISION. THE PATIENT WAS SUBSEQUENTLY REFERRED TO A RETINA SPECIALIST FOR TREATMENT AND MONITORING. THE HYPHEMA WAS CHARACTERIZED AS GRADE 0 (MICRO-HYPHEMA WITH NO VISIBLE LAYERING) WHICH SELF-RESOLVED WITH NO SEQUELAE. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. PER THE SURGEON, THE PATIENT WAS ON ANTICOAGULANTS PREOPERATIVELY, AND THE PATIENT LAID FLAT FOR 12 HOURS AFTER SURGERY. THE PATIENT PROGNOSIS WAS REPORTED AS ¿DOING WELL¿.

    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 DATA FOR THIS DEVICE LOT NUMBER COULD NOT BE REVIEWED. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. VITREOUS HEMORRHAGE, HYPHEMA AND DECREASED/IMPAIRED VISION ARE IDENTIFIED IN THE LABELING AS A KNOWN INHERENT RISK OF TRABECULAR MICRO-BYPASS STENT SURGERY/INTRAOCULAR SURGERY. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING UNEVENTFUL LEFT EYE CATARACT PLUS TRABECULAR MICRO-BYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED WITH VITREOUS HEMORRHAGE ASSOCIATED WITH A VISUAL ACUITY OF "COUNT FINGERS"; ONE (1) DAY POSTOPERATIVELY. FOLLOWING MEDICAL MONITOR CONSULT, THE SURGEON REPORTED THE FOLLOWING. REPORTEDLY, THE PATIENT HAD SLEPT WITH HEAD-OF BED (HOB) FLAT OVERNIGHT (A POSSIBLE CONTRIBUTING FACTOR). THE RETINA APPEARED FINE AND THE PATIENT HAD 4+ RED BLOOD CELLS (RBCS). THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. AT DAY FIVE (5) POST-OP EXAMINATION, THE PATIENT VISION WAS 20/50 (UNCORRECTED) AND THE HEME IN THE ANTERIOR CHAMBER (AC) SETTLED INTO A SMALL HYPHEMA WITH THE VITREOUS HEME CLEARING, AFTER SLEEPING WITH HOB ELEVATED. ADDITIONAL INFORMATION IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842969 ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION G2-M-IS

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other