BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 11872216 · Received May 24, 2021

    Report

    Report Number
    3016075957-2021-00016
    Event Type
    Injury
    Date Received
    May 24, 2021
    Report Date
    September 8, 2021
    Manufacturer
    IVANTIS, INC.
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT FOLLOW-UP INFORMATION AND DEVICE IDENTIFIERS WERE REQUESTED, BUT NOT PROVIDED. THE INSTRUCTIONS FOR USE PROVIDE A PRECAUTION THAT THE SAFETY AND EFFECTIVENESS OF THE HYDRUS MICROSTENT HAS NOT BEEN ESTABLISHED FOR PATIENTS WHO HAVE UNDERGONE PRIOR INCISIONAL GLAUCOMA SURGERY. POTENTIAL SOURCES OF RECURRENT HYPHEMA ARE POSTULATED IN THE CASE PRESENTATION; THE SURGEON SUSPECTED THAT A HIDDEN VESSEL WAS IN CONTACT WITH THE MICROSTENT, CAUSING THE HYPHEMA. ONCE THE DEVICE WAS REPOSITIONED IN THE INFERIOR ANGLE, THERE HAS BEEN NO REPORTED RECURRENCE. ELEVATED IOP AND BLURRY VISION ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. ARTICLE SOURCE: HTTPS://GLAUCOMATODAY.COM/ARTICLES/2021-MAY-JUNE/RECURRENT-HYPHEMA. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    IVANTIS BECAME AWARE OF ADDITIONAL INFORMATION FROM A PUBLISHED CASE PRESENTATION (SOURCE PROVIDED IN H10). THE PATIENT UNDERWENT UNEVENTFUL CATARACT SURGERY AND PLACEMENT OF THE HYDRUS IN EACH EYE. ALTHOUGH IOP REMAINED WELL CONTROLLED WITHOUT MEDICATION AND GONIOSCOPY OF THE MICROSTENT WAS UNREMARKABLE, RECURRENT HYPHEMA IN THE RIGHT EYE BEGAN 18 MONTHS POSTOPERATIVELY WITH TRANSIENT IOP SPIKES AND HAZY VISION LASTING FOR 5 TO 7 DAYS FOLLOWING EACH EPISODE. THE PATIENT HAD A TOTAL OF FOUR EPISODES, THE MOST RECENT OCCURRING 4 WEEKS PRIOR TO INTERVENTION. THE PATIENT'S UNCORRECTED VISUAL ACUITY (UCVA) WAS 20/30 AND UNMEDICATED IOP WAS 14 MMHG. PRIOR TO CATARACT SURGERY AND HYDRUS MICROSTENT IMPLANTATION IN THE RIGHT EYE, THE PATIENT HAD AN INTRAOCULAR PRESSURE (IOP) IN THE UPPER TEENS (ON 2 IOP-LOWERING MEDICATIONS) THAT WAS NOT FULLY CONTROLLED. THE PATIENT COULD NOT TOLERATE MOST EYE DROPS DUE TO AN ALLERGY TO BENZALKONIUM CHLORIDE AND HAD A PRIOR HISTORY OF A SCARRED TRABECULECTOMY IN THE RIGHT EYE. FOLLOWING STENT REPOSITIONING IN THE RIGHT EYE, THE SURGEON REPORTED THE PATIENT WAS VERY SATISFIED, THE EYE WAS ABSENT OF HYPHEMA AND DID NOT REQUIRE ANY IOP-LOWERING MEDICATION.

    Additional Manufacturer Narrative · 1

    THE HYDRUS MICROSTENT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. DEVICE IDENTIFIERS AND ADDITIONAL PATIENT INFORMATION HAVE BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. HYPHEMA, MICROSTENT EXPLANTATION, AND UNPLANNED SECONDARY OCULAR SURGICAL RE-INTERVENTION ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: CMP (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2021 IVANTIS BECAME AWARE OF A SURGICAL VIDEO POSTING ON A (B)(6) ORIGINALLY POSTED ON (B)(6), 2021). IN THIS VIDEO, THE SURGEON REPORTED REMOVING AND REPOSITIONING A HYDRUS MICROSTENT IN THE RIGHT EYE OF A FEMALE PATIENT WHO WAS IMPLANTED APPROXIMATELY TWO YEARS AGO. THE MICROSTENT WAS WELL PLACED IN THE NASAL ANGLE, BUT REQUIRED REMOVAL DUE TO RECURRENT HYPHEMA. DURING HYDRUS REMOVAL, SOME RESISTANCE WAS INITIALLY NOTED AS WELL AS SOME HYPHEMA. FOLLOWING STENT REMOVAL, SLIGHT DAMAGE TO THE PERIPHERAL IRIS WAS REPORTED AND THE SURGEON INDICATED CONCERN FOR A POSSIBLE CYCLODIALYSIS CLEFT. THE SURGEON REENTERED THE EYE USING A NEW INCISION AND PROCEEDED TO REPOSITION THE SAME MICROSTENT INFERIOR TO THE ORIGINAL IMPLANT LOCATION. THE SURGEON CONFIRMED THE MICROSTENT WAS WELL POSITIONED AT THE CONCLUSION OF THE CASE. THE FOLLOWING DAY, THE PATIENT'S INTRAOCULAR PRESSURE (IOP) WAS 14 MMHG WITH NO CLEFT OBSERVED. THE SURGEON INDICATED THE PATIENT HAD DONE WELL, AND THAT THE EYE WAS ABSENT OF HYPHEMA AND DID NOT REQUIRE ANY IOP-LOWERING MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767236 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention