BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 14941534 · Received July 7, 2022

    Report

    Report Number
    3012236936-2022-01737
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    November 11, 2021
    Report Date
    July 6, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE: AGE, MEDIAN (IQR): 58.0 (23.8-63.3). GENDER: FEMALE: 18 (47.4). INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. MODEL NUMBER: THE EXACT MODEL IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED, ONLY INDICATED BAERVELDT-350. THE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). CITATION: ALZENDI NA, ALSHAHWAN S, ALWEHAIB A, ALZABEN K, ALHILALI S, ALKAHTANI A. THE (B)(6) STUDY AT (B)(6) HOSPITAL: THREE-YEAR TREATMENT OUTCOMES.MIDDLE EAST AFR J OPHTHALMOL 2021;28:PP.143-50. 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: THE (B)(6) STUDY AT (B)(6) HOSPITAL: THREE-YEAR TREATMENT OUTCOMES: THIS RETROSPECTIVE, NONRANDOMIZED COMPARATIVE STUDY WAS DONE TO ANALYZE THE OUTCOMES OF TWO FREQUENTLY USED SURGICAL VALVES IN TREATING REFRACTORY GLAUCOMA. A TOTAL OF 86 GLAUCOMA PATIENTS UNDERWENT AHMED-FP7 VALVE (NEW WORLD MEDICAL, INC., (B)(6), CA, USA) OR BAERVELDT-350 (ABBOTT MEDICAL OPTICS, INC., (B)(6), USA) IMPLANTATION USING STANDARDIZED SURGICAL TECHNIQUE. THE PATIENTS WERE GROUPED INTO AHMED (AGV) GROUP (N=48 EYES) AND IN THE BAERVELDT (BGI) GROUP (N=38 EYES). POSTOPERATIVE COMPLICATIONS REPORTED IN THE BGI GROUP WERE AS FOLLOWS: FAILURE/INCREASED IOP (N=17), VISION LOSS/PROGRESSION TO NLP (N=2), ENDOPHTHALMITIS (N=3), SHALLOW AC (N=3), HYPOTONY MACULOPATHY (N=5), VITREOUS HEMORRHAGE (N=5), HYPHEMA (N=1). POSTOPERATIVE INTERVENTIONS REPORTED IN THE BGI GROUP: CYCLOPHOTOCOAGULATION (N=2), TUBE REVISION (N=3), CATARACT REMOVAL (N=3), TUBE REMOVAL (N=1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532348 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention