BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 15029802 · Received July 15, 2022

    Report

    Report Number
    3012236936-2022-01888
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    November 2, 2021
    Report Date
    July 3, 2024
    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

    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)(4). 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), OVERFILTRATION 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. THIS REPORT IS FOR MODEL BG103-250 ADVERSE EVENTS. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTED PRODUCT PROBLEMS 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
    1047764 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG103-250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other