BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 6102730 · Received November 15, 2016

    Report

    Report Number
    1000125279-2016-00014
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Manufacturer
    NEW WORLD MEDICAL, INC
    Product Code
    KYF
    PMA / PMN Number
    K162060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) AS THE ACTUAL DEVICE HISTORY RECORD FOR THE DEVICE INVOLVED IN THIS REPORT COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED CUSTOMER TO OBTAIN FURTHER INFORMATION ON THE LOT NUMBER USED. WITHOUT A LOT NUMBER AVAILABLE, WE CAN NOT COMPLETE A DEVICE HISTORY RECORD REVIEW. WE HAVE REVIEWED OUR CURRENT MANUFACTURING PROCESSES AND NO ISSUES WERE OBSERVED. NO PRODUCT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DR. (B)(6) IS A GLAUCOMA SURGEON WHO PRACTICES AT 2 SITES IN BOSTON. AT THE SITES THEY HAVE A TOTAL OF 6 SURGEONS WHO USE THE AGV-FP7. OVER THE LAST 6 MONTHS THEY HAVE EXPERIENCED UNEXPECTED HYPOTONY (IOP <5) THAT DID NOT RESOLVE WITHOUT INTERVENTION. SHE HAD A TOTAL OF 4 SUCH CASES HERSELF AND 6 CASES REPORTED TO HER BY OTHER SURGEONS. SHE ESTIMATES THE OCCURRENCE TO BE APPROXIMATELY 10% OF HER CASES DURING THIS TIME PERIOD. THE SURGEONS HAVE DIFFERING APPROACHES TO ANTERIOR CHAMBER TUBE INSERTION. SOME USE TUNNELING TECHNIQUE AND SOME INSERTING THE TUBE INTO THE ANTERIOR CHAMBER AT THE LIMBUS. SHE BELIEVES THAT THE HYPOTONY IS TECHNIQUE INDEPENDENT. THEY ARE NOW PUTTING VISCO IN THE ANTERIOR CHAMBER AFTER CASES AND THIS HAS BEEN SUCCESSFUL IN REDUCING HYPOTONY. TWO CASES HAD TO BE ACTIVELY MANAGED. IN ONE CASE THEY HAD TO TIE OFF THE TUBE AND DRAIN CHOROIDAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752608 AHMED GLAUCOMA VALVE GLAUCOMA SHUNT KYF NEW WORLD MEDICAL, INC FP7 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention