BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 6185818 · Received December 19, 2016

    Report

    Report Number
    2032546-2016-00073
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 19, 2016
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    UDI-DI
    00853704002012
    PMA / PMN Number
    P080030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE CUSTOMER AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO NON-CONFORMITIES BELIEVED TO BE RELATED TO THE REPORTED EVENT. ANTERIOR CAPSULAR BAG TEAR IS A KNOWN INHERENT RISK OF GLAUCOMA AND CATARACT SURGERY. (B)(4). SUBMITTED TO FDA:12/19/2016.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: SEX, DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA, OTHER RELEVANT HISTORY, EVALUATION CODES. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE ISTENT PROCEDURE WAS ABORTED AS VISUALIZATION WAS LOST. CLINICAL FOLLOW UP WAS REQUESTED AND ON 11/29/2016 THE SURGEON PROVIDED THAT FOLLOWING EVENT DETAILS. THE PROCEDURE WAS ABORTED DUE TO COMPROMISED/OBSCURED VISUALIZATION. ADDITIONAL ATTEMPTS AND ISTENT IMPLANTATION WERE STOPPED DUE TO CONCERN WITH BAG STABILITY AS A SMALL ANTERIOR CAPSULAR TEAR WAS REPORTED. THERE WAS TRANSIENT INTRA-OPERATIVE BLEEDING THAT WAS SELF-RESOLVING. THE PATIENT¿S CURRENT STATUS WAS REPORTED TO BE DOING WELL THOUGH THE PATIENT MAY REQUIRE ADDITIONAL TREATMENT FOR GLAUCOMA. ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 1

    CLINICAL FOLLOW UP WAS REQUESTED AND ON 2/14/2017 THE SURGEON PROVIDED THE FOLLOWING EVENT DETAILS. THE CAPSULAR BAG TEAR WAS NOTED DURING IRRIGATION AND ASPIRATION AND DID NOT RESULT IN ANY ADVERSE IMPACT TO THE PATIENT. NO INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT STATUS AND PROGNOSIS WAS REPORTED TO BE STABLE. THE PATIENT MAY NEED ADDITIONAL TREATMENT FOR GLAUCOMA AS NO ISTENT WAS IMPLANTED. THE LENS STATUS WAS REPORTED TO BE STABLE AND THE ADVERSE EVENT WAS REPORTED TO HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837932 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION GTS100L 107962 00853704002012

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other