BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT

    MDR report key: 12013238 · Received June 16, 2021

    Report

    Report Number
    9614546-2021-07224
    Event Type
    Injury
    Date Received
    June 16, 2021
    Report Date
    June 16, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: MEAN AGE AT 65.0 ± 14.1 YEARS. SEX/GENDER: 41 % FEMALES PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. RACE/ETHNICITY: WHITE 54.1%, BLACK 21.3%, ASIAN 4.9%, HISPANIC 6.6% INDIAN 0.0% UNKNOWN 13.1% (NOT SPECIFIED IF GROUPED WITH JOHNSON & JOHNSON IMPLANT.) DATE OF EVENT: SEPTEMBER 18 2021 (THE DATE ARTICLE WAS PUBLISHED.) BRAND NAME: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). SHALABY, W., MYERS, J., RAZEGHINEJAD, R., KATZ, L. JAY., PRO, M., DALE, E., FUDEMBERG, S.J., MANTRAVADI, A.V., SHUKLA, A.G. (2021). OUTCOMES OF VALVED AND NONVALVED TUBE SHUNTS IN NEOVASCULAR GLAUCOMA. AMERICAN ACADEMY OF OPHTHALMOLOGY 4(2), PP.182-192. AN ATTEMPT HAS 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 · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: OUTCOMES OF VALVED AND NONVALVED TUBE SHUNTS IN NEOVASCULAR GLAUCOMA A SINGLE-CENTER, RETROSPECTIVE, COMPARATIVE STUDY WAS DONE TO DETERMINE THE OUTCOMES OF AHMED GLAUCOMA VALVE (AGV; NEW WORLD MEDICAL INC) AND BAERVELDT GLAUCOMA IMPLANT (BGI; ADVANCED MEDICAL OPTICS) SURGERY IN THE SETTING OF NEOVASCULAR GLAUCOMA (NVG). A TOTAL OF 152 EYES OF 140 PATIENTS WITH NEOVASCULAR GLAUCOMA (NVG) UNDERWENT EITHER AGV (N=91 EYES) OR BGI (N=61 EYES) IMPLANTATION. POSTOPERATIVE COMPLICATIONS IN THE BGI GROUP INCLUDE SUPRACHOROIDAL HEMORRHAGE (N=4) IN WHICH 2 EYES REQUIRED DRAINAGE IN THE OPERATING ROOM, TUBE EROSION (N=1), HYPOTONY MACULOPATHY (N=1). AT 6 MONTHS POST-OP, 15 EYES IN THE BGI GROUP WERE CLASSIFIED AS FAILURE: 12 WERE DUE TO INTRAOCULAR PRESSURE (IOP) >21 MMHG, 2 WERE DUE TO LOSS OF LIGHT PERCEPTION, AND 1 DUE TO IOP <5 MMHG. IN THE BGI EYES, MEAN LOGMAR VISUAL ACUITY (VA) DECREASED FROM 1.87±0.97 AT BASELINE TO 1.88±1.1 AT THE FINAL VISIT. BY THE FINAL VISIT, 9 EYES IN THE BGI GROUP HAD PROGRESSED TO NO LIGHT PERCEPTION (NLP) VISION WITHOUT A SIGNIFICANT DIFFERENCE BETWEEN THE AGV (17 EYES, 18.7%) AND BGI (9 EYES, 14.8%) GROUPS. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906724 UNK_GLAUCOMA SHUNT_BAERVELDT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNK-GLAUCOMA SHUNT_BAERVELDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention