BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 11784407 · Received May 6, 2021

    Report

    Report Number
    3016075957-2021-00014
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 6, 2021
    Report Date
    May 10, 2021
    Manufacturer
    IVANTIS, INC.
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON BELIEVES THE CAUSE OF THE PATIENT'S ELEVATED IOP WAS DUE TO PROLONGED OCULAR INFLAMMATION AND A STEROID RESPONSE. THE IOP ELEVATION IS NOT SUSPECTED AS BEING RELATED TO THE INITIAL REPORT OF MICROSTENT OBSTRUCTION. THE INSTRUCTIONS FOR USE PROVIDE A PRECAUTION THAT THE SAFETY AND EFFECTIVENESS OF THE HYDRUS MICROSTENT HAS NOT BEEN ESTABLISHED FOR PIGMENTARY GLAUCOMA AND A CAUTION THAT ANTI INFLAMMATORY STEROIDS ARE KNOWN TO CAUSE IOP INCREASE IN SOME PATIENTS. INFLAMMATION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    THE SURGEON PROVIDED THE FOLLOWING PATIENT UPDATE TO IVANTIS ON (B)(6) 2021. ONE WEEK AFTER EXPLANTATION OF THE HYDRUS MICROSTENT, THE PATIENT'S INTRAOCULAR PRESSURE (IOP) PEAKED (43 MMHG) AND ALL STEROIDS WERE SUBSEQUENTLY DISCONTINUED. THE PATIENT WAS THEN PLACED ON DIAMOX (AN IOP-LOWERING MEDICATION) AND THE IOP DECREASED TO 12 MMHG A FEW DAYS LATER. THE SURGEON INITIALLY REPORTED THAT THE EYE WAS QUIET AND THERE WAS NO CORNEAL INFLAMMATION; HOWEVER, THE SURGEON CLARIFIED THAT THE PATIENT EXPERIENCED PROLONGED OCULAR INFLAMMATION. THE PATIENT'S IOP IS CURRENTLY 24 MMHG ON GLAUCOMA DROPS.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED MICROSTENT WAS RETURNED TO IVANTIS FOR EVALUATION AND SUBJECTED TO MICROSCOPIC VISUAL INSPECTION, DIMENSIONAL ANALYSIS, AND FUNCTIONAL TESTING. THE MICROSTENT MET DIMENSIONAL AND VISUAL SPECIFICATIONS. FUNCTIONAL TESTING USING THE MICROSTENT AND THE DELIVERY SYSTEM USED FOR THE EXPLANT PROCEDURE WAS PERFORMED; THE DELIVERY SYSTEM FUNCTIONED AS INTENDED DURING ADVANCEMENT, RELEASE, RETRACTION AND RECAPTURE. DEVICE IDENTIFIERS WERE REQUESTED, BUT NOT AVAILABLE. MICROSTENT MALPOSITION, MICROSTENT-IRIS TOUCH, MICROSTENT OBSTRUCTION, ELEVATED IOP, AND MICROSTENT EXPLANTATION ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2021, A PATIENT WITH MODERATE PIGMENTARY GLAUCOMA UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF THE HYDRUS MICROSTENT IN THE RIGHT EYE. THERE WAS NO REPORT OF A COMPLICATION DURING THE CATARACT PORTION OF THE PROCEDURE, HOWEVER, DURING MICROSTENT IMPLANTATION THE SURGEON NOTED THE STENT WAS FURTHER OUT IN THE ANTERIOR CHAMBER THAN PREFERRED. RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO ADVANCE THE STENT; THEREFORE NO FURTHER ADJUSTMENTS TO THE DEVICE POSITION WERE MADE. PREOPERATIVELY, THE PATIENT'S GLAUCOMA WAS CONTROLLED (15 MMHG) ON 2 IOP-LOWERING MEDICATIONS. ON (B)(6) 2021, THE PATIENT'S INTRAOCULAR PRESSURE (IOP) WAS 24 MMHG. ON (B)(6) 2021, IOP INCREASED TO 34 MMHG ON 2 IOP-LOWERING MEDICATIONS. ON (B)(6) 2021 (2 WEEKS POSTOPERATIVELY), IOP WAS 36 MMHG ON 3 IOP-LOWERING MEDICATIONS AND GONIOSCOPY REVEALED THE TIP OF THE HYDRUS WAS TOUCHING THE IRIS WITH PARTIAL OCCLUSION. ALTHOUGH THE EYE WAS QUIET AND THERE WAS NO CORNEAL INFLAMMATION, NO OCULAR DISCOMFORT, NO CLINICAL SEQUELAE; THE SURGEON PLANNED TO EXPLANT THE MICROSTENT. IN ADDITION, THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) IMPROVED FROM 20/40 (PREOPERATIVELY) TO 20/20 (PRIOR TO EXPLANTATION). ON (B)(6) 2021, THE MICROSTENT WAS EXPLANTED WITHOUT COMPLICATION. ON (B)(6) 2021, THE PATIENT'S IOP WAS 33 MMHG ON THE SAME 3 IOP-LOWERING MEDICATIONS AND BCVA REMAINED UNCHANGED. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT. THE CAUSE OF THE IOP ELEVATION IS NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683260 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention