BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISTENT INJECT

    MDR report key: 11855256 · Received May 20, 2021

    Report

    Report Number
    11855256
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 7, 2021
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    A SECOND EYE STENT DID NOT DEPLOY PROPERLY. MD ATTEMPTED TO THREAD THE STENT BACK ON, THEN THERE WAS NO MORE CLICKS/ADVANCEMENTS AVAILABLE IN THE DELIVERY SYSTEM. SO, DOCTOR DECIDED TO ONLY DEPLOY 1 STENT. PROTECT HAD PATIENT CONTACT BUT NO PATIENT HARM. MANUFACTURER RESPONSE FOR ISTENT TRABEC MICRO BYPS MULTI, (BRAND NOT PROVIDED) (PER SITE REPORTER). REACHED OUT TO FIELD REP WITH NO RESPONSE.

    Description of Event or Problem · 1

    A SECOND EYE STENT DID NOT DEPLOY PROPERLY. MEDICAL DOCTOR ATTEMPTED TO THREAD THE STENT BACK ON, THEN THERE WAS NO MORE CLICKS/ADVANCEMENTS AVAILABLE IN THE DELIVERY SYSTEM. SO, DOCTOR DECIDED TO ONLY DEPLOY 1 STENT. PROTECT HAD PATIENT CONTACT BUT NO PATIENT HARM. MANUFACTURER RESPONSE FOR ISTENT TRABEC MICRO BYPS MULTI, (BRAND NOT PROVIDED) (PER SITE REPORTER). REACHED OUT TO FIELD REP WITH NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756023 ISTENT INJECT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION G2-M-IS-US 104956

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA