BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 11497112 · Received March 16, 2021

    Report

    Report Number
    1000125279-2021-00002
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 9, 2021
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    UDI-DI
    00892064002119
    PMA / PMN Number
    K162060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED FOR COMPLIANCE AND NO ISSUES WERE OBSERVED. THE PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED PER NEW WORLD MEDICAL'S (NWM) APPROVED PROCEDURES. THE SAMPLE WAS NOT RETURNED TO NWM; THEREFORE, THE ISSUE REPORTED COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    PER DOCTOR "I NEEDED TO APPLY A LOT OF FORCE TO THE EYE POST-OP TO GET FLUID TO GO THROUGH THE AHMED AND A BLEB TO FORM." PATIENT HAS SEVERE PRIMARY OPEN ANGLE GLAUCOMA (POAG). PRE-OP IOP WAS 25MMHG. POST-OP DAY 1 IOP WAS 20MMHG. POST-OP WEEK 1 IOP AROUND 20MMHG AND HAD FLAT BLEB OVER THE TUBE PLATE. POST-OP WEEK 2 IOP AT 8MMHG (AFTER INFERIOR GLOBE MASSAGE), LARGE BLEB FORMED OVER THE TUBE PLATE, ALLOWING THE DR. TO FORCE SOME FLUID THROUGH AND GET THE TUBE TO START FILTERING. PATIENT IS ON A STEROID Q2 TO INHIBIT CONJUNCTIVAL SCARRING, AND ON PROSTAGLANDIN INHIBITOR FOR IOP. POST-OP WEEK 3-4 IOP IS 17MMHG ON NO GTTS, AND BLEB LOOKS BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392141 AHMED GLAUCOMA VALVE AGV MODEL FP7 KYF NEW WORLD MEDICAL, INC. FP7 H1320 00892064002119

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention