BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 11750324 · Received April 29, 2021

    Report

    Report Number
    3016075957-2021-00011
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 29, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIRST HYDRUS MICROSTENT (REMOVED INTRAOPERATIVELY BY SURGEON) WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THE SECOND DEVICE WAS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. BOTH DEVICES WERE FROM THE SAME LOT. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. BASED ON REVIEW OF THE SURGICAL CASE, SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE MICROSTENT AGAINST EXCESSIVE RESISTANCE, WHICH RESULTED IN FORMATION OF THE IRIDODIALYSIS CLEFT. THE SURGEON ALLEGED THAT THE MICROSTENT WAS BENT AND DUE TO THE BEND THE MICROSTENT WOULD NOT ADVANCE FURTHER; HOWEVER, THERE WAS NO EVIDENCE OF THE IMPLANT BEING BENT AT ANY TIME DURING THE PROCEDURE. THE IMPLANT IS DESIGNED TO BE FLEXIBLE. THE FLEXIBILITY OF THE MICROSTENT IN THE VIDEO APPEARED NORMAL. BASED ON MEDICAL REVIEW OF THE CASE, THE ROOT CAUSE OF THE IRIDODIALYSIS AND SEQUELAE WAS ATTRIBUTED TO USE ERROR WHERE EXCESSIVE FORCE WAS APPLIED (IN BOTH RADIAL AND COUNTERCLOCKWISE DIRECTIONS) DURING THE IMPLANTATION ATTEMPT AND OTHER SUBSEQUENT ATTEMPTS TO REPOSITION THE MICROSTENT. THE INVESTIGATIONAL LABELING INCLUDES THE FOLLOWING WARNING, "IF EXCESSIVE RESISTANCE IS ENCOUNTERED DURING THE INSERTION OF THE MICROSTENT AT ANY TIME DURING THE PROCEDURE, DISCONTINUE USE OF THE DEVICE. CONTINUING TO INSERT THE MICROSTENT AGAINST RESISTANCE IN THE INSERTION PROCESS MAY RESULT IN INJURY TO THE PATIENT OR DAMAGE TO THE MICROSTENT." IRIDODIALYSIS AND HYPOTONY ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. THIS REPORT IS BEING FILED FOR THE FIRST HYDRUS MICROSTENT THAT WAS NOT IMPLANTED. REFER TO MDR #3016075957-2021-00012 FOR THE REPORT ON THE SECOND HYDRUS MICROSTENT THAT WAS IMPLANTED SUCCESSFULLY. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    SUBJECT IN AN (B)(6) STUDY UNDERWENT HYDRUS IMPLANTATION IN THE LEFT EYE ON (B)(6) 2021. DURING THE INITIAL ATTEMPT AT HYDRUS IMPLANTATION, THE MICROSTENT WAS NOT PROPERLY POSITIONED (I.E., ANTERIOR PLACEMENT). WHILE ATTEMPTING TO ADJUST THE DEVICE POSITION WITH A SINSKEY HOOK, THE SURGEON INADVERTENTLY CREATED A SMALL (< 1 CLOCK HOUR) IRIDODIALYSIS. HE INDICATED THAT THE MICROSTENT WAS BENT PREVENTING HIM FROM ADVANCING IT FURTHER, SO HE RECAPTURED AND REMOVED IT FROM THE EYE. ON THE SECOND ATTEMPT AND USING A NEW DEVICE, THE SURGEON SUCCESSFULLY IMPLANTED THE HYDRUS MICROSTENT, HOWEVER, ATTEMPTS AT ADVANCING THE STENT FURTHER INTO SCHLEMM'S CANAL WITH THE SINSKEY HOOK RESULTED IN REMOVAL OF THE TRABECULAR MESHWORK (TM) LOCATED AT THE TRANSITION ZONE OF THE DEVICE AND ENLARGEMENT OF THE IRIDODIALYSIS (1-2 CLOCK HOURS). PREOPERATIVELY, ON (B)(6) 2021, THE SUBJECT'S BASELINE BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/26 AND DIURNAL INTRAOCULAR PRESSURE (IOP) WAS 28 MMHG (ON 4 IOP-LOWERING MEDICATIONS). TWO HOURS AFTER SURGERY, IOP WAS 27 MMHG (ON THE SAME 4 IOP-LOWERING MEDICATIONS). ON (B)(6) 2021, IOP WAS 8 MMHG (ON THE SAME 4 IOP-LOWERING MEDICATIONS) AND THE IRIDODIALYSIS HAD RESOLVED. ON (B)(6) 2021, IOP DECREASED TO 4.5 MMHG (ON THE SAME 4 IOP-LOWERING MEDICATIONS) WITH A DEEP ANTERIOR CHAMBER; ONE IOP-LOWERING MEDICATION WAS DISCONTINUED. ON (B)(6) 2021, IOP INCREASED TO 7 MMHG (ON 3 IOP-LOWERING MEDICATIONS). THE SUBJECT'S NEXT SCHEDULED VISIT IS IN APPROXIMATELY 1 MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643125 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00020 20900145 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention