BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 6538660 · Received May 2, 2017

    Report

    Report Number
    2032546-2017-00027
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    January 1, 2016
    Report Date
    April 19, 2017
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE SOURCE: FERGUSON, T. J. , BERDAHL, J.P., SCHWEITZER, J.A. & SUDHAGONI, R. CLINICAL EVALUATION OF A TRABECULAR MICROBYPASS STENT WITH PHACOEMULSIFICATION IN PATIENTS WITH OPEN-ANGLE GLAUCOMA AND CATARACT. CLINICAL OPHTHALMOLOGY. 2016 (10): 1767-1773 DOI: 10.2147/OPTH.S114306. DEVICE IDENTIFIERS ARE NOT AVAILABLE. THE DEVICES REMAIN IMPLANTED IN THE PATIENTS AND ARE NOT AVAILABLE FOR EVALUATION. IOP ELEVATION IS IDENTIFIED IN THE DEVICE LABELING AS A KNOWN INHERENT RISK OF GLAUCOMA STENT SURGERY. (B)(4).

    Description of Event or Problem · 1

    THROUGH REVIEW OF THE ARTICLE ¿CLINICAL EVALUATION OF A TRABECULAR MICROBYPASS STENT WITH PHACOEMULSIFICATION IN PATIENTS WITH OPEN-ANGLE GLAUCOMA AND CATARACT¿ IT WAS LEARNED THAT ONE DAY POSTOPERATIVELY, 31 EYES EXPERIENCED AN INTRAOCULAR PRESSURE (IOP) INCREASE OF 15 MM HG ABOVE THEIR BASELINE IOP THAT RESPONDED TO TOPICAL THERAPY. THE STUDY WAS COMPRISED OF 350 EYES (217 FEMALE, 133 MALE) WITH A MEAN AGE OF 74.05 +/- 8.97, AND EVALUATED THE SAFETY AND EFFICACY OF THE ISTENT TRABECULAR MICROBYPASS STENT IN COMBINATION WITH CATARACT SURGERY IN PATIENTS WITH OPEN-ANGLE GLAUCOMA (OAG). POSTOPERATIVELY, PATIENTS WERE PRESCRIBED ANTIBIOTICS FOR ONE WEEK, NSAIDS FOR FOUR WEEKS, AND STEROID DROPS FOR ONE MONTH, WHICH STARTED AS QID AND WERE TAPERED TO BID AFTER ONE WEEK. PATIENTS WERE KEPT ON THEIR PREOPERATIVE OCULAR HYPOTENSIVE MEDICATIONS FOR AT LEAST ONE WEEK AND UNTIL THE PATIENT'S IOP WAS DEEMED CLINICALLY ACCEPTABLE BY THE OPERATING PHYSICIAN. NO SPECIFIC GUIDELINES WERE ESTABLISHED TO DETERMINE WHEN TO ADD OR REMOVE OCULAR HYPOTENSIVE MEDICATIONS, AND MEDICATION ADDITION OR REMOVAL WAS BASED ON CLINICAL JUDGMENT. IN THIS STUDY, THE MEAN DECREASE IN IOP WAS NEARLY 4 MM HG AT SIX MONTHS POSTOPERATIVELY, WITH A SUSTAINED REDUCTION THROUGH TWO YEARS POSTOPERATIVELY. THE STUDY CONCLUDED THAT IMPLANTATION OF THE ISTENT EFFECTIVELY LOWERED IOP IN OAG PATIENTS, AND THAT MEDICATION USE WAS SIGNIFICANTLY REDUCED POSTOPERATIVELY. NO IDENTIFYING INFORMATION WAS COLLECTED IN THE DATA COLLECTION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318769 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention