BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 17213995 · Received June 27, 2023

    Report

    Report Number
    3012236936-2023-01575
    Event Type
    Injury
    Date Received
    June 27, 2023
    Report Date
    June 27, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K905129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE DEVICE WAS EXPLANTED. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: DOLEZAL KA, MD, JACOBSON A, MD, BESIRLI CG, MD, PHD, ELNER V, BOHNSACK BL. MD, PHD. SCLERAL HISTOPATHOLOGIC FINDINGS OF HURLER-SCHEIE SYNDROME WITH REFRACTORY GLAUCOMA. AMA OPHTHALMOL. MARCH 2022;140(3): PP. 285-287. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON LITERATURE REVIEW. ARTICLE: SCLERAL HISTOPATHOLOGIC FINDINGS OF HURLER-SCHEIE SYNDROME WITH REFRACTORY GLAUCOMA A CASE REPORT WAS DONE TO DESCRIBE A 2-YEAR-OLD GIRL WITH HURLER-SCHEIE SYNDROME RECEIVING IDURONIDASE ENZYME REPLACEMENT THERAPY AND WAS DIAGNOSED WITH SECONDARY GLAUCOMA BASED ON HIGH INTRAOCULAR PRESSURE (IOP) AND INCREASED CUP-DISC RATIO. THE PATIENT WAS INSERTED WITH A BAERVELDT 101-350 (ABBOTT MEDICAL OPTICS) GLAUCOMA DRAINAGE DEVICE THAT SUCCESSFULLY LOWERED THE IOP IN THE RIGHT EYE AND REMAINED STABLE IN THE UPPER TEENS FOR 3 YEARS POSTOP. THE SURGERY WAS COMPLICATED BY PROLONGED CHOROIDAL EFFUSION AND THE IOP IN THE LEFT EYE REMAINED ELEVATED DESPITE TRABECULOTOMY AND BAERVELDT 101-350 GLAUCOMA DRAINAGE DEVICE PLACEMENT. SUBSEQUENTLY, THREE 4 × 4-MM SCLERAL WINDOWS WERE CREATED AT THE EQUATOR OF THE LEFT EYE, WHICH REDUCED IOP TO THE LOW TEENS OVER 3 YEARS OF FOLLOW-UP. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. THIS REPORT PERTAINS TO PATIENT'S LEFT EYE. THE RIGHT EYE WAS DETERMINED TO BE NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702115 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG101-350

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female Other