BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 9795833 · Received March 5, 2020

    Report

    Report Number
    2032546-2020-00026
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    December 30, 2019
    Report Date
    April 16, 2020
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MFR# (B)(4). PLEASE REFERENCE 2032546-2020-00028 FOR REPORTED STENT OCLUSSIONS.

    Description of Event or Problem · 0

    THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. ACCORDING TO THE SURGEON, THE STENT CAUSED OR CONTRIBUTED TO THE REPORTED POSTOPERATIVE EVENTS IN NARROW ANGLES EYES. THE PATIENT¿S IOP WAS REPORTED AS ¿STILL CONTROLLED¿. THIS FOLLOW-UP REPORT IS ASSOCIATED WITH INITIAL REPORT OF SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PUBLICATION ACCEPTANCE DATE WAS USED. THE DEVICES WERE NOT AVAILABLE; THEREFORE, PRODUCT TESTING ON THESE ACTUAL DEVICES COULD NOT BE PERFORMED. THE DEVICE IDENTIFIERS WERE NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS FOR THIS DEVICE LOT NUMBER COULD NOT BE REVIEWED. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. HYPHEMA, CORNEAL EDEMA, IRIS DAMAGE AND STENT OBSTRUCTION ARE IDENTIFIED IN THE LABELING AS KNOWN INHERENT RISKS 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. THE IFU NOTES THAT THE SAFETY AND EFFECTIVENESS OF THE TRABECULAR MICRO BYPASS STENT HAS NOT BEEN ESTABLISHED FOR IMPLANTATION IN PATIENT WITH PRIMARY ANGLE CLOSURE GLAUCOMA. MFR#: (B)(4). PLEASE REFERENCE 2032546-2020-00028 FOR REPORTED STENT OCLUSSIONS. (B)(4).

    Description of Event or Problem · 1

    THROUGH A REVIEW OF AN ARTICLE TITLED ¿PHACOEMULSIFICATION VERSUS PHACOEMULSIFICATION WITH MICROBYPASS STENT IMPLANTATION IN PRIMARY ANGLE CLOSURE AND PRIMARY ANGLE CLOSURE GLAUCOMA: A RANDOMIZED SINGLE-MASKED CLINICAL STUDY ¿, THE FOLLOWING WAS REPORTED IN THE PHACO-ISTENT GROUP. REPORTEDLY, FOLLOWING CATARACT PLUS STENT PROCEDURES, THERE WERE POSTOPERATIVE COMPLICATIONS CONSISTED OF STENT OCCLUSION WITH IRIS WHICH OCCURRED IN FIVE (5) EYES. PER REPORT, ONE (1) EYE REQUIRED GLAUCOMA MEDICATION AT ONE (1) MONTH POSTOP AND ANOTHER EYE REQUIRED GLAUCOMA MEDICATION AT THREE (3) MOTHS POST-OPERATIVELY. IN ADDITION, A CORNEAL EDEMA OCCURRED IN ONE (1) EYE, HYPHEMA (1), IRIS ATROPHY (1) AND ENDOTHELIAL BLOOD STAINING (1). AS REPORTED, ALL POSTOPERATIVE COMPLICATIONS DID NOT REQUIRE ANY SECONDARY SURGICAL INTERVENTION TO REPOSITION OR REPLACE THE STENT. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT REFERENCES THE REPORTED SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258519 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention