BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 18837660 · Received March 5, 2024

    Report

    Report Number
    3016075957-2024-00015
    Event Type
    Injury
    Date Received
    March 5, 2024
    Report Date
    June 11, 2024
    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. LITERATURE ARTICLE: MANAGING PRIMARY OPEN-ANGLE GLAUCOMA IN THE SETTING OF SUBOPTIMAL SURGICAL OUTCOMES IN THE FELLOW EYE (J CATARACT REFRACT SURG. (B)(6) 2023; 49(7): 764). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION SITE FOR EVALUATION FOR THE REPORT OF RISE IN IOP AFTER INSERTION OF A HYDRUS MICROSTENT AND TRABECULECTOMY; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION SITE AND NO LOT INFORMATION IS AVAILABLE, 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

    THIS LITERATURE REPORT HAS RECEIVED FROM REGULATORY AGENCY STATING "A 62-YEAR-OLD WOMAN WITH MILD MYOPIA PRESENTED TO HER LOCAL OPTOMETRIST FOR A ROUTINE EXAMINATION AND WAS FOUND TO HAVE INTRAOCULAR PRESSURE (IOP) OF 30 MM HG IN BOTH EYES AND CUPPED NERVES.WE ELECTED TO PERFORM LEFT EYE CATARACT SURGERY COMBINED WITH 360-DEGREE VISCOCANALOPLASTY AND INSERTION OF A MICROSTENT.HOWEVER, BY POSTOPERATIVE WEEK 3, IOP (INTRAOCULAR PRESSURE) RETURNED TO 27 MM HG, AND DESPITE RESTARTING PROSTAGLANDIN AGONISTS¿RHO KINASE INHIBITORS AND FINISHING HER STEROID TAPER, IOP REMAINED AT 27 MM HG BY POSTOPERATIVE WEEK 6. ALPHA ADRENERGIC AGONISTS¿BETA BLOCKER WAS ADDED BACK TO HER LEFT EYE REGIMEN AND AT POSTOPERATIVE WEEK 8, IOP HAD ELEVATED TO 45 MMHG. MAXIMIZING HER THERAPY WITH THE ADDITION OF TOPICAL CARBONIC ANHYDRASE INHIBITORS AND ORAL CARBONIC ANHYDRASE INHIBITORS BROUGHT HER IOP BACK DOWN TO 30 MM HG. AT THAT POINT, THE DECISION WAS MADE TO PROCEED WITH TRABECULECTOMY OF THE LEFT EYE. THE TRABECULECTOMY WAS UNEVENTFUL. HOWEVER, POSTOPERATIVE ATTEMPTS TO AUGMENT FILTRATION WERE RENDERED LESS SUCCESSFUL BY EXTREMELY THICK TENON LAYER. AT HER MOST RECENT FOLLOW-UP THE PRESSURE IN THE LEFT EYE WAS MIDTEENS WITH ALPHA ADRENERGIC AGONISTS¿BETA BLOCKER AND CARBONIC ANHYDRASE INHIBITORS. LITERATURE CITATION: HUANG ET AL. MANAGING PRIMARY OPEN-ANGLE GLAUCOMA IN THE SETTING OF SUBOPTIMAL SURGICAL OUTCOMES IN THE FELLOW EYE. J CATARACT REFRACT SURG. (B)(6) 2023; 49(7): 764.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882215 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC NA ASKU 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| O BRIMONIDINE.| DORZOLAMIDE.| LATANOPROST.| METHAZOLAMIDE.| NETARSUDIL.| TIMOLOL.