BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 8546951 · Received April 24, 2019

    Report

    Report Number
    2032546-2019-00053
    Event Type
    Injury
    Date Received
    April 24, 2019
    Report Date
    April 24, 2019
    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

    AGE OR DATE OF BIRTH: (MEAN AGE USED), SEX: (MODE USED). THE DEVICES WERE NOT AVAILABLE FOR RETURNED; THEREFORE, PRODUCT TESTING ON THESE ACTUAL DEVICES COULD NOT BE PERFORMED. DEVICE IDENTIFIERS WERE NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS FOR THIS DEVICE LOT NUMBER COULD NOT BE REVIEWED. ELEVATED IOP 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). THIS STUDY WAS A CONTINUATION AND EXPANSION OF A PREVIOUS STUDY, REFERENCE MFR# (B)(4).

    Description of Event or Problem · 1

    THROUGH A REVIEW OF THE ARTICLE "TRABECULAR MICRO BYPASS STENT IMPLANTATION IN PSEUDOPHAKIC EYES WITH OPEN-ANGLE GLAUCOMA: LONG-TERM RESULTS¿, THE FOLLOWING WAS REPORTED. NO CASES OF HYPOTONY OCCURRED POSTOPERATIVELY. THERE WERE NO INTRAOPERATIVE OR POSTOPERATIVE COMPLICATIONS OBSERVED RELATED TO THE STENT. FOR PRESSURE SPIKES ABOVE BASELINE, ONLY 3 (5.7%) OF THE 51 EYES EXPERIENCED AN IOP SPIKE OF 15 MM HG OR HIGHER AND 8 EYES (15.3%) HAD IOP SPIKES OF 10 MM HG OR HIGHER, ALL OCCURRING WITHIN 1 MONTH AFTER SURGERY. THIS WAS RETROSPECTIVE ANALYSIS OF DATA COLLECTED FROM 51 EYES OF 40 PATIENTS. PATIENTS WITH MILD TO SEVERE OPEN ANGLE GLAUCOMA WERE IMPLANTED WITH 1 TRABECULAR MICRO BYPASS STENT. PURPOSE: TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF A TRABECULAR MICRO BYPASS STENT AS A SOLE PROCEDURE IN PSEUDOPHAKIC EYES WITH OPEN-ANGLE GLAUCOMA. CONCLUSION: THE INSERTION OF A SINGLE TRABECULAR MICRO BYPASS STENT EFFECTIVELY PROVIDED A SUSTAINED REDUCTION IN IOP PSEUDOPHAKIC PATIENTS WITH MILD TO SEVERE OAG. THE IOP REDUCTION WAS MORE ROBUST IN EYES THAT HAD A HIGHER BASELINE IOP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338807 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other