BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 17263005 · Received July 5, 2023

    Report

    Report Number
    3012236936-2023-01699
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    March 8, 2023
    Report Date
    July 5, 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 A-2 PATIENT AGE YEARS, MEDIAN (IQR): (VALUE % ALL EYES (N=110): 74.5 (68, 82), (CONSERVATIVE MANAGEMENT-MEDICATIONS, AC VISCOELASTIC INJECTIONS; N=91): 74 (67.5,82.5), AND (SURGICAL MANAGEMENT-SURGICAL DRAINAGE, GDI TUBE LIGATION; N=19): 73 (69, 81.5). NOT SPECIFIED IF GROUPED WITH JOHNSON & JOHNSON IMPLANT. SECTION A-3 GENDER: (VALUE % ALL EYES (N=110): MALE - 51(46%) FEMALE - 59(54%), (CONSERVATIVE MANAGEMENT-MEDICATIONS, AC VISCOELASTIC INJECTIONS; N=91): MALE 41(45%) FEMALE - 50 (55%), AND (SURGICAL MANAGEMENT-SURGICAL DRAINAGE, GDI TUBE LIGATION; N=19): MALE - 10(53%) FEMALE - 9 (47%). NOT SPECIFIED IF GROUPED WITH JOHNSON & JOHNSON IMPLANT.. SECTIONS A-4 PATIENT WEIGHT, AND A-5 PATIENT ETHNICITY AND RACE: UNKNOWN/NOT PROVIDED. SECTION B-3: DATE OF EVENT: THE DATE ARTICLE WAS ACCEPTED: 08-MAR-2023. SECTION D-4 MODEL NUMBER: UNKNOWN, AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. ONLY PROVIDED AS BGI-350. SECTION D-4 CATALOG NUMBER: UNKNOWN, AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. THE ONLY INFORMATION PROVIDED WAS BG-350. SECTION D-4 DEVICE SERIAL NUMBER: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION D-4 DEVICE EXPIRATION DATE: UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-4 UDI NUMBER: THE UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-6A DATE IMPLANTED: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION D-6B DATE EXPLANTED: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION H3-81: SECTION H3-81: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IN ADDITION DEVICE SERIAL NUMBER 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 H-4 DEVICE MANUFACTURE DATE: UNKNOWN, AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION H-6 HEALTH EFFECT - CLINICAL CODE: 4581 SHALLOWING OR COLLAPSING OF THE ANTERIOR CHAMBER. CITATION: YING, S., ARA J. COULON, S.J, LIDDER, A.K. LABOWSKY, M., CHENG, C.P., VINOD, K., SIDOTI, P.A., PANARELLI, J.F. (2023). CHOROIDAL EFFUSIONS AFTER GLAUCOMA DRAINAGE IMPLANT SURGERY: RISK FACTORS AND SURGICAL MANAGEMENT. OPHTHALMOLOGY GLAUCOMA, PP. 1-11. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO 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: CHOROIDAL EFFUSIONS FOLLOWING GLAUCOMA DRAINAGE IMPLANT SURGERY: RISK FACTORS AND SURGICAL MANAGEMENT. A RETROSPECTIVE CASE SERIES WAS DONE TO REPORT THE INCIDENCE OF PATIENTS WHO DEVELOPED CHOROIDAL EFFUSIONS AFTER GLAUCOMA DRAINAGE IMPLANT (GDI) SURGERY AND DETERMINE RISK FACTORS FOR AND OUTCOMES OF SURGICAL INTERVENTION. PATIENTS (N=605 PATIENTS) RECEIVED EITHER A 350-MM2 BGI (BGI-350), A 250-MM2 BGI (BGI-250), OR AN AHMED (FP7) GLAUCOMA VALVE IMPLANT (AGV). POSTOPERATIVE COMPLICATIONS INCLUDED: CHOROIDAL EFFUSION: 110 PATIENTS (BGI-250, N=27; BGI-350, N=28; FP7, N=55) THE CHOROIDAL EFFUSION IN 91 PATIENTS (BGI-250, N=22; BGI-350, N=19; FP7, N=50) WAS RESOLVED WITH CONSERVATIVE MANAGEMENT ALONE (CONSERVATIVE MANAGEMENT GROUP: ADJUSTMENT OF THE MEDICAL REGIMEN, N=53; AND ANTERIOR CHAMBER (AC) VISCOELASTIC INJECTION, N=38); 19 PATIENTS (BGI-250, N=5; BGI-350, N=9; FP7, N=5) REQUIRED SURGICAL DRAINAGE (N=10) AND GDI TUBE LIGATION (N=2), CLASSIFIED AS SINGLE SURGICAL INTERVENTION GROUP; THE REMAINING PATIENTS (N=7) HAD ADDITIONAL SURGICAL INTERVENTION AS RESOLUTION (MULTIPLE SURGICAL INTERVENTION GROUP), WHICH WERE: GDI TUBE LIGATION (N=3), SECOND SURGICAL DRAINAGE PROCEDURE (N=3), AND GDI REMOVAL AND PLACEMENT OF A NEW DEVICE WITH A SMALLER ENDPLATE (N=1). LOST >2 LINES OF SNELLEN VISUAL ACUITY (OVERALL CONSERVATIVE GROUP, N=24; OVERALL SURGICAL MANAGEMENT GROUP, N=10) ANTERIOR CHAMBER SHALLOWING (AC; P < 0.001; OR, 25.1, NO ACTUAL COUNT) SECONDARY COMPLICATIONS WERE: IN THE CONSERVATIVE MANAGEMENT GROUP: CORNEAL DECOMPENSATION (N=4) AND TRANSIENT CHOROIDAL FOLDS (N=3); IN THE SINGLE SURGICAL INTERVENTION GROUP: SEIDEL-POSITIVE CORNEAL WOUND (N=1); IN THE MULTIPLE SURGICAL INTERVENTION GROUP: RETINAL DETACHMENT (N=1) IT IS UNCLEAR HOWEVER, IF IT WAS OUR DEVICE OR THE OTHER DEVICE IN THE GROUP THAT WAS IMPLANTED IN THE AFFECTED EYES. THERE WERE NO FURTHER INTERVENTIONS REPORTED. THIS REPORT CAPTURES ADVERSE EVENTS FOR INCOMPLETE MODEL BG-350. A SEPARATE REPORT WILL CAPTURE ADVERSE EVENTS FOR BG103-250.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973060 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNK_GLAUCOMA BAERVELDT SHUNT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention