BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 12013414 · Received June 16, 2021

    Report

    Report Number
    3016075957-2021-00024
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    April 29, 2021
    Report Date
    October 27, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: SECTION B5-DATE OF EVENTS UPDATED, ONSET OF EVENTS OCCURRED AT 3 WEEKS AND NOT 5-7 DAYS POSTOPERATIVELY. SECTION B6- IOP WAS REPORTED AS 8MMHG ON (B)(6) 2012 AND CORRECTED TO 6MMHG. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND ALL RELEASED PRODUCTS MET SPECIFICATION. THE SEQUELAE REPORTED IN THIS EVENT ARE MULTIFACTORIAL WITH IRIDODIALYSIS, IOP FLUCTUATIONS, CORNEAL EDEMA, INFLAMMATION AND PAS ALL POTENTIALLY INTERRELATED; ALL ARE LISTED AS POTENTIAL ADVERSE EFFECTS IN THE DEVICE INSTRUCTION FOR USE (C00256). THEREFORE, NO FURTHER INVESTIGATION IS DEEMED NECESSARY. THIS TYPE OF COMPLAINT WILL BE MONITORED FOR TRENDS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION TO IVANTIS PERTAINING TO THIS EVENT: APPROXIMATELY 3 WEEKS ((B)(6) 2021) POSTOPERATIVE, THE PATIENT REPORTED ACUTE ONSET OF OCULAR PAIN AND BLURRY VISION. UNMEDICATED IOP WAS 38 MMHG, CORNEAL EDEMA/BULLAE WERE PRESENT, AND PERIPHERAL ANTERIOR SYNECHIAE (PAS) WERE EVIDENT ON THE MICROSTENT INLET. THREE IOP-LOWERING MEDICATIONS, A MORE POTENT STEROID AND TOPICAL SODIUM CHLORIDE HYPERTONIC SOLUTION WERE ADDED TO THE MEDICATION REGIMEN. THE FOLLOWING DAY ((B)(6)2021), BCVA WAS 20/80 WITH 2+ AC CELLS AND A FOCAL IRIDODIALYSIS; IOP WAS 14 MMHG ON 3 IOP-LOWERING MEDICATIONS. SODIUM CHLORIDE HYPERTONIC SOLUTION WAS SUBSEQUENTLY DISCONTINUED. THE PATIENT SHOWED PROGRESSIVE IMPROVEMENT OUT TO THE 6-WEEK FOLLOW-UP ((B)(6) 2021) WITH BCVA IMPROVED TO 20/25, RARE CELLS (2-3 CELLS ONLY VISIBLE ON HIGH POWERED FIELD VIEW), AND IOP WAS 10 MMHG ON 2 IOP-LOWERING MEDICATIONS AND NO FURTHER REPORT OF CORNEAL EDEMA/BULLAE; THE TOPICAL STEROID AND NON-STEROIDAL ANTI-INFLAMMATORY MEDICATIONS WERE CONTINUED.

    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. THE INSTRUCTIONS FOR USE INCLUDE A CAUTION TO BE CAREFUL WHEN REENGAGING THE INTERLOCK WITH THE MICROSTENT TO AVOID INADVERTENT CAPTURE OF TISSUE BETWEEN THE INTERLOCK AND IMPLANT. SIGNIFICANT IRIS INJURY OR TRAUMA, OCULAR PAIN, BLURRY VISION, AND ELEVATED IOP ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE SURGEON CONTACTED IVANTIS REGARDING A MALE PATIENT WHO HAD A HYDRUS MICROSTENT IMPLANTED CONCURRENT WITH CATARACT SURGERY APPROXIMATELY 7-10 DAYS PRIOR. INITIALLY, THE SURGEON ATTEMPTED TO IMPLANT THE MICROSTENT PRIOR TO CATARACT SURGERY, BUT WAS UNSUCCESSFUL AFTER TWO ATTEMPTS DUE TO POSTERIOR PLACEMENT. AFTER THE FIRST UNSUCCESSFUL IMPLANT ATTEMPT AND WHILE ATTEMPTING TO RECAPTURE AND WITHDRAW THE HYDRUS, THE DELIVERY SYSTEM GRASPED AND TORE SOME PERIPHERAL IRIS TISSUE. THE SURGEON PROCEEDED WITH CATARACT SURGERY SUCCESSFULLY AND THEN RE-ATTEMPTED HYDRUS IMPLANTATION. THE FIRST REATTEMPT AT MICROSTENT IMPLANTATION WAS UNSUCCESSFUL (DUE TO POSTERIOR PLACEMENT), HOWEVER, THE MICROSTENT WAS SUCCESSFULLY POSITIONED IN SCHLEMM'S CANAL ON THE SECOND REATTEMPT. AT ONE DAY POSTOPERATIVELY, THE PATIENT'S INTRAOCULAR PRESSURE (IOP) DECREASED TO 8 MMHG; SLIT-LAMP EXAMINATION (SLE) SHOWED THE ANTERIOR CHAMBER (AC) WAS DEEP WITH 1-2+ CELLS. AT APPROXIMATELY 5-7 DAYS POSTOPERATIVELY, THE PATIENT REPORTED SUDDEN ONSET OF (EYE) PAIN AND BLURRY VISION. IOP WAS ELEVATED AND BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/80; SLE CONFIRMED THE AC REMAINED DEEP WITH 1-2+ AC CELLS. THE SURGEON DID NOT HAVE AN OBVIOUS EXPLANATION AND REFERRED THE PATIENT TO A RETINAL SPECIALIST FOR FURTHER EVALUATION. THE POSSIBILITY OF A SUPRACHOROIDAL HEMORRHAGE WAS DISCUSSED, BUT GIVEN THE LIMITED AVAILABLE INFORMATION, NOTHING COULD BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906575 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 20900427 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Disability| R