BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 19342366 · Received May 17, 2024

    Report

    Report Number
    1000125279-2024-00017
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 13, 2024
    Report Date
    May 17, 2024
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    UDI-DI
    00892064002119
    PMA / PMN Number
    K230975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT WAS REVIEWED, AND NO ISSUES WERE OBSERVED. THE PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED PER VALIDATED PROCEDURES. DURING THE VISUAL TEST, A CUT WAS IDENTIFIED ON THE TUBE OF THE DEVICE. IT'S IMPORTANT TO HIGHLIGHT THAT NEW WORLD MEDICAL INC. CONDUCTS 100% TESTING OF ITS PRODUCTS BEFORE THEY REACH THE MARKET. THE REPORTED DEVICE WAS EVALUATED IN COMPLIANCE WITH NWM PROCEDURES. THE DEVICE WAS TESTED FOR STEADY STATE PRESSURE PAST THE SECTION WERE THE TUBE CUT OBSERVED AND FUNCTIONED WITHIN SPECIFICATION, THE DOCTOR REPORTED THE FOLLOWING: "IN THE FIRST SURGERY ON (B)(6) 2024, PRIMING WAS NO PROBLEM. AFTER 8 WEEKS POST-OP, HIGH IOP REMAINED. TO CHECK THE VALVE THE SECOND SURGERY WAS CONDUCTED ON (B)(6) AND THE DOCTOR DID PRIMING AGAIN, AND SAW WATER COMING OUT FROM THE ROOT OF THE TUBE. THAT VALVE WAS REMOVED AND REPLACED WITH OTHER ONE. THE DOCTOR IS CONCERNED THAT THERE MIGHT HAVE BEEN A POSSIBILITY THAT HE COULD HAVE DAMAGED THE REMOVED VALVE WHEN CHECKING AND PRIMING FOR THE SECOND TIME." IT WAS CONFIRMED THAT THERE WERE NO PRIMING ISSUES OR LEAKS FOUND IN THE PRODUCT FROM THE FIRST SURGERY, INDICATING THAT THE TUBE MAY HAVE BEEN DAMAGED DURING THE SECOND SURGERY. WHILE IT REMAINS UNCLEAR WHAT SPECIFICALLY CAUSED THE HIGH IOP,

    Description of Event or Problem · 0

    IN THE FIRST SURGERY ON (B)(6) 2024, PRIMING WAS NO PROBLEM. AFTER 8 WEEKS POST-OP, HIGH IOP REMAINED. TO CHECK THE VALVE THE SECOND SURGERY WAS CONDUCTED ON (B)(6) AND THE DOCTOR DID PRIMING AGAIN, AND SAW WATER COMING OUT FROM THE ROOT OF THE TUBE. THAT VALVE WAS REMOVED AND REPLACED WITH OTHER ONE. THE DOCTOR IS CONCERNED THAT THERE MIGHT HAVE BEEN A POSSIBILITY THAT HE COULD HAVE DAMAGED THE REMOVED VALVE WHEN CHECKING AND PRIMING FOR THE SECOND TIME, BUT HE IS ASKING FOR INVESTIGATION. THE PATIENT'S IOP, POST-OP: 25MMHG, AT 6 WEEK POST OP: 20MMHG, AND IT WAS LOWERED TO 7MMHG AFTER THE SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531018 AHMED GLAUCOMA VALVE GLAUCOMA DRAINAGE DEVICE KYF NEW WORLD MEDICAL, INC. FP7 K1923 00892064002119

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention