BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 5502501 · Received March 15, 2016

    Report

    Report Number
    9614546-2016-00113
    Event Type
    Injury
    Date Received
    March 15, 2016
    Report Date
    March 15, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFG DATE: DEVICE MANUFACTURE DATE: UNKNOWN, SINCE SERIAL NUMBER NOT KNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE: AFSHAR AR, HEMARAT K, LIU W, WANG S, STEWART JM. OUTER RETINAL ATROPHY ON SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY AFTER RESOLUTION OF GLAUCOMA SURGERY-ASSOCIATED HYPOTONY MACULOPATHY. RETINAL CASES AND BRIEF REPORTS. 2016;10(1):96-99. A (B)(6)-YEAR-OLD WOMAN WITH HLA-B27- POSITIVE UVEITIS, PSEUDOPHAKIA, AND PREVIOUS TRABECULECTOMY FOR UVEITIC GLAUCOMA PRESENTED WITH RECURRENT UNCONTROLLED UVEITIC GLAUCOMA IN THE LEFT EYE. INTRAOCULAR PRESSURE WAS 35 MMHG DESPITE MAXIMAL MEDICAL THERAPY, WITH PROGRESSIVE VISUAL FIELD DEFECTS. THE PATIENT ELECTED FOR A BAERVELDT GLAUCOMA DRAINAGE DEVICE AT AN OUTSIDE INSTITUTION. PREOPERATIVE VISION WAS 20/60 WITH NORMAL OUTER RETINAL LAYERS ON SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY (SD-OCT). TEN DAYS AFTER SURGERY, VISION WAS HAND MOTIONS WITH INTRAOCULAR PRESSURE (IOP) OF 0 MMHG AND A LARGE SEIDEL-NEGATIVE BLEB. POSTOPERATIVE WEEK 2, VISION AND IOP WERE UNCHANGED, AND FUNDUSCOPIC EXAMINATION SHOWED DISK SWELLING, SEVERE MACULAR FOLDS, AND RETINAL VASCULAR TORTUOSITY, WITHOUT CHOROIDAL DETACHMENT. SD-OCT SHOWED "CHOROIRETINAL" FOLDS AND LOSS OF THE OUTER NUCLEAR LAYER, EXTERNAL LIMITING MEMBRANE (ELM), AND ELLIPSOID (EZ). THE TUBE SHUNT AND OVERLYING SCLERAL NAP WERE RESUTURED. TEN DAYS LATER (1 MONTH AFTER GLAUCOMA DRAINAGE DEVICE SURGERY), VISION WAS FINGER-COUNTING WITH IOP OF 7 MMHG. MACULAR STRIAE RESOLVED. SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY AGAIN SHOWED LOSS OF THE OUTER NUCLEAR LAYER, ELM, AND EZ. FOUR MONTH AFTER GLAUCOMA DRAINAGE DEVICE IMPLANTATION , VISION, IOP, AND SD-OCT REMAINED STABLE, AND THE PATIENT NOTED PERSISTENT BLURRED CENTRAL VISION. THE EYE WAS QUIET THROUGHOUT THE POSTOPERATIVE COURSE WITH NO UVEITIS WHILE HYPOTONUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156885 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention