BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 18073631 · Received November 6, 2023

    Report

    Report Number
    3016075957-2023-00044
    Event Type
    Injury
    Date Received
    November 6, 2023
    Date of Event
    October 11, 2023
    Report Date
    November 29, 2023
    Manufacturer
    IVANTIS INC
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MICROSTENT WAS NOT RETURNED TO MANUFACTURING SITE AND IS NOT AVAILABLE FOR EVALUATION. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW, LOT COMPLAINT HISTORY REVIEW, AND NON-CONFORMANCE REVIEW COULD NOT BE CONDUCTED. IT WAS REPORTED THAT FOLLOWING A MICROSTENT IMPLANT PROCEDURE, POST OPERATION DAY 1 INTRAOCULAR PRESSURE (IOP) WAS ELEVATED AND MICROSTENT DISTAL END NOT IN CANAL AND ON IRIS. THE REPORTING SURGEON STATED THAT "THE PATIENT'S RADIUS OF CURVATURE IS LARGER THAN MICROSTENT, AND JUST DID NOT SEEMS TO BE FIT." AFTER STENT WAS REMOVED WITH NO COMPLICATIONS, TUBE SHUNT WAS PERFORMED. IOP NEXT DAY WAS 24 ON NO DROPS AND CORNEA CLEAR. THE MICROSTENT WAS NOT RETURNED TO MANUFACTURING SITE AND IS NOT AVAILABLE FOR EVALUATION. THE IMPLANTING SURGEON ALLEGED DEVICE MOVEMENT, SUSPECTING PATIENT ANATOMY AS A CAUSE, HOWEVER, THE CONSULTATION INCLUDED ADVICE FOR "MOVING GONIO LENS AROUND TO BE SURE STENT IS 100% IN CANAL" SUGGESTING THAT THE MICROSTENT MAY HAVE BEEN POSITIONED INCORRECTLY DURING SURGERY. MIGRATION IS NOT CONFIRMED; THE ROOT CAUSE OF THIS EVENT AND CLINICAL ISSUES REPORTED IS UNKNOWN. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT, FOLLOWING AN MICROSTENT IMPLANT PROCEDURE, POST OPERATION DAY 1 INTRAOCULAR PRESSURE (IOP) WAS ELEVATED SO LOOKED IN ANGLE AND STENT WAS OUT OF ANGLE. PROXIMAL PART IS IN SCHLEMMS BUT DISTAL 2/3 IS STICKING OUT AND LYING ON TOP OR IRIS. EYE SEEMED LARGE DURING CASE, NOT HIGH MYOPE BY FLOPPY DEEP AC (ANTERIOR CHAMBER) AND THE IOL LOOKED SMALL IN BAG. SEEMS LIKE RADIUS OF CURVATURE OF EYE IS BIGGER THAN RADIUS OF MICROSTENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE SURGEON AND STATED THAT MICROSTENT DISTAL END NOT IN CANAL AND ON IRIS. AS PER THE SURGEONS OPINION, THE PATIENT'S RADIUS OF CURVATURE IS LARGER THAN MICROSTENT, AND JUST DID NOT SEEMS TO BE FIT. SURGEON STATED THAT, OMNI (OTHER MINIMALLY INVASIVE GLAUCOMA PROCEDURE) WAS DID FIRST. THE POST OPERATIVE IOP SPIKE TO 40'S REQUIRING URGENT TUBE PLACEMENT. SURGEON ALSO STATED THAT, THERE WAS SOME RESISTANCE WITH OMNI BUT DID CANALIZE SUCCESSFULLY. THE OTHER HEMI THERE WAS SIGNIFICANT RESISTANCE AND SO SURGEON DID NOT CANALIZE. ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE SURGEON AND OBSERVED THAT THE STENT THAT WAS PARTIALLY OUT OF SC (WITH OUT CORRECTION) WITH DISTAL END VISIBLE IN AC (ANTERIOR CHAMBER) ANGLE ON GONIO. ACCORDING TO SURGEON, PATIENT'S IOP WAS IN THE 40'S WITH 4+ CORNEAL EDEMA REQUIRING FURTHER INTERVENTION AND A VISIT TO THE OR (OPERATION ROOM). AFTER STENT WAS REMOVED WITH NO COMPLICATIONS, TUBE SHUNT WAS PERFORMED. IOP NEXT DAY WAS 24 ON NO DROPS AND CORNEA CLEAR. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951922 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC NA ASKU 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other