BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAERVELDT SHUNT

    MDR report key: 15029880 · Received July 15, 2022

    Report

    Report Number
    3012236936-2022-01889
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    November 2, 2021
    Report Date
    July 5, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K905129
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE/DATE OF BIRTH: 63.1 (11.2). SEX/GENDER: 13 (59.1%) MALES AND 9 (40.9%) FEMALES; NOT SPECIFIED IF GROUPED WITH JOHNSON & JOHNSON IMPLANT. WEIGHT: UNKNOWN/NOT PROVIDED. RACE: 9 (40.9%) BLACK, 11 (50.0%) WHITE, 2 (9.1%) OTHER; NOT SPECIFIED IF GROUPED WITH JOHNSON & JOHNSON IMPLANT. ETHNICITY: 6 (27.3%) HISPANIC OR LATINO, 16 (72.7%) NOT HISPANIC OR LATINO. DATE OF EVENT: AS THERE IS NO ARTICLE DATE LISTED ON THIS STUDY, THE "LAST UPDATE POSTED" DATE FROM CLINICALTRIALS.GOV IS BEING USED, WHICH IS (B)(6) 2021. SERIAL NUMBER: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UNIQUE IDENTIFIER (UDI) NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THERE WAS NO SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4). FELDMAN, R. THE AMERICAN GLAUCOMA SOCIETY (AGS) SECOND AQUEOUS SHUNT IMPLANT VS. TRANSSCLERAL CYCLOPHOTOCOAGULATION TREATMENT STUDY (ASSISTS). CLINICALTRIALS.GOV IDENTIFIER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER REVIEW, IT WAS NOTED THAT SECTION D4 CATALOG NUMBER WAS SUBMITTED AS BG103-250 ON THE INITIAL MDR, BUT SHOULD BE 23030819. THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT. THE FOLLOWING FIELD HAS BEEN UPDATED ACCORDINGLY: SECTION D4: CATALOG NUMBER: 23030819. 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: THE AMERICAN GLAUCOMA SOCIETY (AGS) SECOND AQUEOUS SHUNT IMPLANT VS. TRANSSCLERAL CYCLOPHOTOCOAGULATION TREATMENT STUDY (ASSISTS). A RANDOMIZED INTERVENTIONAL STUDY WAS DONE TO COMPARE OUTCOMES OF PATIENTS WITH UNCONTROLLED GLAUCOMA WITH A SINGLE EXISTING AQUEOUS TUBE SHUNT IMPLANT UNDERGOING A SECOND AQUEOUS SHUNT TO TRANSSCLERAL DIODE LASER CYCLOPHOTOCOAGULATION (TLC). A TOTAL OF 42 EYES OF THE 50 ENROLLED EYES RECEIVED THE ASSIGNED INTERVENTION AND WERE GROUPED INTO SECOND AQUEOUS SHUNT (SAS) GROUP (N= 22 EYES) AND TRANSSCLERAL CYCLOPHOTOCOAGULATION (TLC) GROUP (N=20 EYES). HOWEVER, ONLY 12 EYES (N=7 EYES AND N=5 EYES, RESPECTIVELY) COMPLETED THE STUDY. FOR THE SAS GROUP, EITHER A BAERVELDT GLAUCOMA IMPLANT 350-MM2 BG101-350 OR AN AHMED MODEL FP7 FLEXIBLE PLATE WAS USED UNLESS THERE IS INSUFFICIENT SPACE, WHEREIN A BAERVELDT GLAUCOMA IMPLANT 250-MM2 BG103-250 WAS USED. TRANSSCLERAL DIODE LASER CYCLOPHOTOCOAGULATION WAS USED WITH THE TLC GROUP. SERIOUS ADVERSE EVENTS INCLUDED: HYPHEMA (N=1 EYE); CENTRAL NERVOUS SYSTEM (CNS) SYPHILIS CAUSING PAN UVEITIS (N=1 EYE); AND DEATH (N=3), BUT CAUSE OF DEATH WERE NOT REPORTED. OTHER REPORTED EVENTS WERE: CHOROIDALS (N=1), CORNEAL EPITHELIAL DEFECT (N=1), DECREASED VISUAL ACUITY (N=2), DEVELOPMENT OF CYSTOID, MACULAR EDEMA (N=1), DIABETIC MACULAR EDEMA (N=1), ECTROPION (N=1), FILAMENTARY KERATITIS (N=1), HERPES SIMPLEX VIRUS DENDRITIC KERATITIS (N=1), HYPHEMA (N=1), HYPOTONY OF EYE (N=1), OVER FILTRATION OF EYE (N=1), RE-EXPOSED TUBE (N=1), SUPERIOR NASAL TUBE WITH <1 MM EXPOSURE AT LIMBUS (ORIGINAL TUBE) (N=1), TRABECTOME/GONIOTOMY OF EYE (N=1), TUBE MIGRATION ANTERIORLY (N=1), VISION LOSS FROM COUNT FINGERS TO LIGHT PERCEPTION(N=1), VITREOUS CLOGGING OF SECOND TUBE SHUNT (N=1), LEAK/INFLAMMATION OR INFECTION OF EYE (N=1), INCIDENCE OF PAIN ¿ 12 PARTICIPANTS (57.1%). IT WAS NOT CLEAR WHETHER THESE COMPLICATIONS OCCURRED IN EYES WITH THE BAERVELDT SHUNT OR THE OTHER COMPETITOR PRODUCT. THERE WERE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. THIS REPORT IS FOR MODEL BG103-250 PRODUCT PROBLEMS. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTED ADVERSE EVENTS FOR THIS MODEL. ADDITIONALLY, A SEPARATE REPORT IS BEING SUBMITTED FOR MODEL BG101-350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2722450 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG103-250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown