BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 19901024 · Received August 2, 2024

    Report

    Report Number
    3012236936-2024-000212
    Event Type
    Injury
    Date Received
    August 2, 2024
    Report Date
    August 2, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE TRABECULECTOMY 66.6 ± 11.7 GDD 66.1 ± 14.1. SECTION A3: INFORMATION UNKNOWN/NOT PROVIDED. TOTAL COUNT IS 70 PATIENTS. SECTIONS A4, A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE: 16 FEBRUARY 2024. SECTION D4: CATALOG NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: UNKNOWN/ NOT PROVIDED. SECTION D6B - EXPLANT DATE: N/A, GLAUCOMA IMPLANTS REMAIN IMPLANTED. SECTION H3: THE IMPLANTS WERE NOT RETURNED FOR EVALUATION AS THEY REMAIN IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: CAROLINE GIETZELT · LILO KOENIG · WERNER ADLER · FRIEDERIKE SCHAUB · LUDWIG M. HEINDL · CLAUS CURSIEFEN · THOMAS S. DIETLEIN · PHILIP ENDERS. A COMPARATIVE STUDY OF CYSTOID MACULA EDEMA FOLLOWING GLAUCOMA DRAINAGE DEVICE SURGERY VERSUS TRABECULECTOMY. MARCH 2024. INT OPHTHALMOL (2024) 44: P. 150 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 A LITERATURE REVIEW: ARTICLE: A COMPARATIVE STUDY OF CYSTOID MACULA EDEMA FOLLOWING GLAUCOMA DRAINAGE DEVICE SURGERY VERSUS TRABECULECTOMY A RETROSPECTIVE STUDY WAS DONE TO ASSESS AND COMPARE THE RISK FOR DEVELOPMENT OF CYSTOID MACULA EDEMA (CME) AFTER GLAUCOMA DRAINAGE DEVICE (GDD) IMPLANTATION VERSUS CONVENTIONAL TRABECULECTOMY WITH MITOMYCIN (TRAB) FOR GLAUCOMA. A TOTAL OF 73 EYES OF 70 PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA (POAG), PIGMENT DISPERSION GLAUCOMA (PDG) OR PSEUDOEXFOLIATION GLAUCOMA (PXG) UNDERWENT EITHER TRABECULECTOMY WITH MMC (N=42 EYES) OR SURGERY WITH GDD IMPLANTATION (N=31 EYES). OF THE PATIENTS RECEIVING GDD IMPLANTS, N=28 PATIENTS RECEIVED A BAERVELDT IMPLANT AND N=3 PATIENTS RECEIVED AN AHMED IMPLANT IN THIS STUDY. AMONG THE PATIENTS RECEIVING A GDD, 5 EYES DEVELOPED CME. POST-OPERATIVE COMPLICATIONS REPORTED INCLUDE POST-OPERATIVE HYPOTONY (N=2 EYES) IN WHICH INJECTION OF HEALON INTO ANTERIOR CHAMBER OR INSERTION OF ADDITIONAL SUTURE WAS DONE; POST-OPERATIVE ELEVATED INTRAOCULAR PRESSURE (IOP) (N=2 EYES) IN WHICH REVISION SURGERY WAS NECESSARY; AND CONJUNCTIVAL DEHISCENCE (N=1 EYE) IN WHICH SURGERY WAS NECESSARY. ONE EYE REQUIRED SHORTENING OF THE TUBE POST-OPERATIVELY. IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN THE EYES IMPLANTED WITH BAERVELDT IMPLANT OR THE OTHER PRODUCT. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994969 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention