BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 4345991 · Received December 12, 2014

    Report

    Report Number
    1000125279-2014-00004
    Event Type
    Injury
    Date Received
    December 12, 2014
    Report Date
    November 21, 2014
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    PMA / PMN Number
    K060644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DIRECT ASSESSMENT OF THE PRODUCT COULD NOT BE CONDUCTED AS THE DEVICE WAS NOT RETURNED. HOWEVER BASED ON THE PUBLISHED CASE REPORT, IT APPEARS THAT THE DEVICE WAS NOT IMPLANTED IN ACCORDANCE WITH THE DIRECTIONS FOR USE, LIKELY CAUSING THE DIPLOPIA AND ELEVATED INTRAOCULAR PRESSURE.

    Description of Event or Problem · 1

    UPON REVIEW OF A CASE REPORT "EXPLANTATION OF THE NOVEL AHMED GLAUCOMA VALVE M4 IMPLANT" AUTHORED BY WANDA D. HU ET AL AND PUBLISHED ON THE JOURNAL OF FLAUCOMA EPUBLICATION, WWW.GLAUCOMAJOURNAL.COM, VOLUME 00, NUMBER 00, 2014. THE CASE STUDY DISCUSSES AN EXPLANTED VALVE DUE TO DIPLOPIA AND REPLACED WITH ANOTHER M4. PER THE ARTICLE IT WAS CASE 3: " A (B)(6) WOMAN PRESENTED AN ELEVATED IOP OF 26MM HG AFTER A PRIOR SUPRACILIARY GLOD SHUNT IMPLANTATION (SOLX, (B)(4)) AND FAILED TRABECULOTOMY FOR PRIMARY OPEN-ANGLE GLAUCOMA. AN AGV M4 WAS PLACED SUPEROTEMPORALLY WITH TUTOPLAST PERICARDIAL PATCH GRAFT (RTI BIOLOGICS, ALACHUA, FL). AT THE POSTOPERATIVE WEEK 1 VISIT, THE PT WAS NOTED TO HAVE BINOCULAR DIPLOPIA. FORTY-TWO DAYS AFTER SURGERY, THE PT STILL HAD INTRACTABLE BINOCULAR DIPLOPIA AND THE IOP ELEVATED TO 23 MM HG. THE DECISION WAS MADE AT THIS TIME TO EXPLANT THE CURRENT AGV, MR. INTRAOPERATIVELY, THE INITIAL AGV M4 WAS FOUND TO BE OVER THE SUPERIOR RECTUS. THE ENTIRE DEVICE WAS REMOVED AND A NEW AGV M4 IMPLANT WITH VISIONGRAFT WAS PLACED MORE TEMPORALLY, AVOIDING THE RECTI MUSCLES. TEN MONTHS POSTOPERATIVELY, THE PT WAS DOING WELL WITH MODERATE IOP CONTROL ON BIMATOPROST 0.01 PERCENT (LUMIGAN, IRVING, CA). COMBIGAN, AND AZOPT)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807807 AHMED GLAUCOMA VALVE GLAUCOMA HUNT KYF NEW WORLD MEDICAL, INC. M4 N0112

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention