BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 21596918 · Received March 13, 2025

    Report

    Report Number
    3016075957-2025-00014
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    February 19, 2025
    Report Date
    June 10, 2025
    Manufacturer
    IVANTIS INC
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION SITE FOR EVALUATION FOR THE REPORT OF GRANULOMATOUS INFLAMMATORY REACTION, BLURRY VISION, FLOATERS, AND INTRAOCULAR PRESSURE INCREASE; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT DURING THE POST OPERATIVE WEEK ONE VISIT AFTER THE STENT IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND FLOATERS SINCE POST OPERATIVE DAY 5. THE PATIENT HAD DIFFUSE GRANULOMATOUS KERATIC PRECIPITATES (KPS), ANTERIOR CHAMBER AND VITREOUS CELL. THE PHYSICIAN DID TAP AND INJECT JUST TO BE SAFE, BUT CONJUNCTIVA WAS WHITE AND QUIET, NO PAIN, DIDN¿T REALLY SEEM LIKE ENDOPHTHALMITIS. THE PHYSICIAN THOUGHT IT COULD BE EARLY SYMPATHETIC OPHTHALMIA OR REACTION TO STENT (GRANULOMATOUS INFLAMMATORY REACTION). ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING POST-OPERATIVELY, GRANULOMATOUS UVEITIS WAS FIRST NOTED ON POST-OPERATIVE DAY 8, ACCOMPANIED BY WORSENED VISION AND ELEVATED INTRAOCULAR PRESSURE. GIVEN THE PRESENTATION OF ANTERIOR CHAMBER AND VITREOUS CELL WITHIN ONE WEEK OF SURGERY, THE CONDITION HAD INITIALLY BEEN TREATED AS A POSSIBLE CASE OF POST-OPERATIVE ENDOPHTHALMITIS. THE PATIENT UNDERWENT A VITREOUS TAP AND RECEIVED AN INTRAVITREAL INJECTION OF CEPHALOSPORIN ANTIBIOTICS AND GLYCOPEPTIDE ANTIBIOTICS ON THE SAME DAY. THE PATIENT HAD BEEN LAST SEEN ON POST OPERATIVE DAY 14 (LAST SEEN DATE), AT WHICH POINT BACTERIAL CULTURES AND VIRAL PCR FROM THE VITREOUS FLUID HAD BEEN NEGATIVE, RULING OUT INFECTIOUS ENDOPHTHALMITIS AND HERPETIC INFECTION. THE CLINICAL CONDITION HAD SHOWN IMPROVEMENT WITH FREQUENT TOPICAL STEROID USE, AND THE INFLAMMATION WAS EXPECTED TO CONTINUE RESOLVING. POST-OPERATIVE MEDICATIONS HAD INCLUDED CORTICOSTEROIDS, QUINOLONE ANTIBIOTICS, NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, CEPHALOSPORIN ANTIBIOTICS, AND GLYCOPEPTIDE ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481258 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC NA 24800017 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other AND THE FOLLOWING DAY, VALTREX 500 MG TID ADDED| CIPROLFOXACIN QID,| KETOROLAC QID| PREDNISOLONE INCREASED TO Q1H.| PREDNISOLONE QID,| S/P INTRAVITREAL INJECTION OF CETAZIDIME| S/P INTRAVITREAL INJECTION OF VANCOMYCIN.