BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 12008330 · Received June 16, 2021

    Report

    Report Number
    3016075957-2021-00022
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 16, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYDRUS MICROSTENT WAS RETURNED TO IVANTIS WITH THE IMPLANT ATTACHED TO THE CANNULA. MICROSCOPIC VISUAL INSPECTION REVEALED THE CANNULA TIP WAS SIGNIFICANTLY BENT. EXCEPT FOR THE BENT CANNULA TIP, ALL OTHER DEVICE DIMENSIONS WERE WITHIN SPECIFICATIONS. THE DEVICE APPEARED TO BE PROPERLY PACKAGED AND SHEATHED FOR RETURN SHIPMENT. THE DAMAGED CONDITION OF THE DEVICE PRECLUDED FUNCTIONAL TESTING. THE CAUSE OF THE ALLEGED DEVICE MALFUNCTION (MICROSTENT WOULD NOT RELEASE FROM THE DELIVERY SYSTEM) IS UNKNOWN. THE OBVIOUS CANNULA TIP DAMAGE WOULD LIKELY HAVE BEEN DETECTED BEFORE INITIAL USE; IT IS THEREFORE PRESUMED THAT THE DEVICE CONDITION WAS DUE TO HANDLING AFTER USE RATHER THAN A MANUFACTURING, QUALITY, OR TRANSPORTATION ISSUE. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. THE DEVICE LABELING AND SURGICAL TRAINING PROGRAM INCLUDE RELEVANT INSTRUCTIONS AND CAUTIONS TO AVOID AND MANAGE IMPLANT RELEASE ISSUES. INABILITY TO IMPLANT THE MICROSTENT, HYPHEMA, ELEVATED IOP, AND UNPLANNED SECONDARY OCULAR SURGICAL RE-INTERVENTION ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2021, A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT UNEVENTFUL CATARACT SURGERY WITH ATTEMPTED HYDRUS MICROSTENT IMPLANTATION IN THE LEFT EYE. THE SURGEON STATED THAT SCHLEMM'S CANAL WAS SCLEROTIC, BUT HE WAS ABLE TO THREAD THE MICROSTENT SUCCESSFULLY. DURING THE PROCEDURE, THE MICROSTENT WOULD NOT RELEASE FROM THE DELIVERY SYSTEM; THE SURGEON STATED IT WAS "COMPLETELY JAMMED". DURING REMOVAL OF THE MICROSTENT FROM THE EYE, THE TRABECULAR MESHWORK WAS UNROOFED DUE TO INABILITY TO RETRACT THE DEVICE, CAUSING HYPHEMA. ON (B)(6) 2021, THE PATIENT'S INTRAOCULAR PRESSURE (IOP) WAS "VERY HIGH" AND THE SURGEON RELAYED TO THE PATIENT THAT THE MICROSTENT COULD NOT BE PROPERLY PLACED, SO SHE WOULD LIKELY REQUIRE FILTERING GLAUCOMA SURGERY SOON. THE SURGEON ALSO REPORTED THAT THIS ALLEGED DEVICE MALFUNCTION HAS OCCURRED SEVERAL TIMES IN THE PAST, BUT THIS WAS THE WORST CASE AND WILL LEAD TO THE LIKELY NEED FOR ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909097 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 20900486 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention| S