BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 7861294 · Received September 10, 2018

    Report

    Report Number
    2032546-2018-00083
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    May 29, 2018
    Report Date
    September 10, 2018
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    UDI-DI
    008537040020
    PMA / PMN Number
    P080030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE; THEREFORE, PRODUCT TESTING ON THE ACTUAL DEVICE COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO NON-CONFORMITIES FOUND TO BE RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW WAS COMPLETED. THE ELECTRONIC COMPLAINT SYSTEM WAS SEARCHED FOR LOT 112794. FIVE (5) COMPLAINTS WERE REVIEWED FOR SIMILARITY. NO SIMILAR EVENTS WERE IDENTIFIED. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. IRITIS IS IDENTIFIED IN THE LABELING AS A KNOWN INHERENT RISK OF TRABECULAR MICRO-BYPASS STENT/INTRAOCULAR SURGERY. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THERE ARE NUMEROUS FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDING BUT NOT LIMITED TO; PATIENT HISTORY, MEDICATION USE, USER ISSUES, AND OPERATIONAL CONTEXT. A CAUSAL LINK BETWEEN THE REPORTED EVENT AND DEVICE COULD NOT BE IDENTIFIED AT THIS TIME. MFR REFERENCE # (B)(4) FOR PATIENT FIVE (5) OF FIVE (5)- LEFT EYE. PLEASE REFERENCE: 2032546-2018-00064 FOR PATIENT ONE (1) OF FIVE (5); 2032546-2018-00079 FOR PATIENT TWO (2) OF FIVE (5); 2032546-2018-00080 FOR PATIENT THREE (3) OF FIVE (5); 2032546-2018-00081 FOR PATIENT FOUR (4) OF FIVE (5); 2032546-2018-00082 FOR PATIENT FIVE (5) OF FIVE (5)- RIGHT EYE.

    Description of Event or Problem · 1

    AS REPORTED INITIALLY, THE SURGEON BELIEVES THAT IMPLANTED STENTS HAVE CAUSED CHRONIC IRITIS WITHIN HIS PREDOMINANTLY AFRICAN-AMERICAN PATIENT POPULATION. THE SURGEON REPORTED THAT AN INORDINATE AMOUNT OF HIS PATIENTS (UNSPECIFIED NUMBER) SEEMINGLY HAVE PROLONGED IRITIS POSTOPERATIVELY, OTHERWISE UNREMARKABLE CATARACT EXTRACTION. THE SURGEON ALSO INDICATED THAT NOTHING OUT OF THE ORDINARY HAS BEEN NOTICED IN ANY OF HIS OTHER PATIENTS. THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. AFTER UNDERGOING BILATERAL CATARACT PLUS TRABECULAR MICRO BYPASS STENT PROCEDURES, THE PATIENT PRESENTED WITH SECONDARY NON-INFECTIOUS IRITIS IN BOTH EYES (OU) POSTOPERATIVELY. THE IRITIS WAS FIRST OBSERVED APPROXIMATELY FIFTEEN (15) WEEKS POSTOP IN THE RIGHT EYE (OD), AND THIRTEEN (13) WEEKS POSTOP IN THE LEFT EYE (OS). THE PATIENT WAS TREATED WITH STEROIDS (PREDNISOLONE & DUREZOL). THE PATIENT¿S MOST RECENT STATUS WAS REPORTED AS ACTIVE IRITIS; SLOWLY IMPROVING, BUT CILIARY FLUSH IN LEFT EYE GREATER THAN RIGHT EYE. THE SURGEON HAS NO FURTHER INFORMATION TO PROVIDE. THIS REPORT REFERENCES PATIENT FIVE (5) OF FIVE (5) FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703313 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION GTS100L 112794 008537040020

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention