BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 10505572 · Received September 8, 2020

    Report

    Report Number
    9614546-2020-00386
    Event Type
    Injury
    Date Received
    September 8, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGES/DATE(S) OF BIRTH (YRS): 64.9 +/- 16.5 ANTERIOR CHAMBER INSERTION (AC), 67.5 ± 12.6 VITREOUS CAVITY INSERTION (VC). GENDER(S)SEX(ES): UNKNOWN, NOT PROVIDED. DATE(S) OF EVENT: UNKNOWN, NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED. SERIAL#: UNKNOWN, INFORMATION WAS NOT PROVIDED. UNIQUE IDENTIFIER: UDI# IS UNKNOWN AS THE SERIAL NUMBERS WERE NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION WAS NOT PROVIDED. EXPLANT DATE: N/A (NOT APPLICABLE) AS THERE IS NO INDICATION THAT THE DEVICES WERE EXPLANTED. INITIAL REPORTER PHONE NUMBER: (B)(6). THE DEVICES WERE NOT RETURNED FOR ANALYSIS (THEY REMAIN IMPLANTED). THERE WERE NO SERIAL NUMBERS REPORTED FOR THESE DEVICES; 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 SERIAL NUMBERS WERE NOT PROVIDED. (B)(4). CITATION: TOJO, N., HAYASHI, A., HAMADA, M., (2019). EFFECTS OF BAERVELDT GLAUCOMA IMPLANT SURGERY ON CORNEAL ENDOTHELIAL CELLS OF PATIENTS WITH NO HISTORY OF TRABECULECTOMY. CLINICAL OPHTHALMOLOGY, 13, PP. 2333¿2340. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. ALL PERTINENT INFORMATION AVAILABLE TO (B)(6) SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: EFFECTS OF BAERVELDT GLAUCOMA IMPLANT SURGERY ON CORNEAL ENDOTHELIAL CELLS OF PATIENTS WITH NO HISTORY OF TRABECULECTOMY. A RETROSPECTIVE STUDY WAS DONE TO INVESTIGATE THE EFFECT OF BAERVELDT GLAUCOMA IMPLANT (BGI) SURGERY ON CORNEAL ENDOTHELIAL CELLS OF PATIENTS WITH NO HISTORY OF TRABECULECTOMY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: BGI INSERTION IN THE ANTERIOR CHAMBER (AC) AND BGI INSERTED IN THE VITREOUS CAVITY (VC). BGI INSERTION IN THE AC: (N=3) EYES REQUIRED TO UNDERGO ADDITIONAL UNSPECIFIED GLAUCOMA SURGERY, (N=4) EYES TO UNDERGO ADDITIONAL SURGERY TO CHANGE THE TUBE POSITION, (N=1) LOSS OF LIGHT PERCEPTION, (N=3) PERSISTENT CORNEAL EDEMA. BGI INSERTION IN THE VC: (N=2) EYES TO UNDERGO ADDITIONAL GLAUCOMA SURGERY, (N=1) INTRAOCULAR PRESSURE (IOP) >21 MM HG, (N=3) LOSS OF LIGHT PERCEPTION, (N=1) PERSISTENT CORNEAL EDEMA. THE STUDY ALSO REPORTED FOUR EYES EXCLUDED FROM THE DATA (DUE TO EXCLUSION CRITERIA OF HAVING A PREVIOUS TRABECULECTOMY DONE) WHEREIN A BAERVELDT TUBE WAS INSERTED INTO THE AC AND THERE WAS A RAPID DECREASE IN THE ECD (N=4). AS A SOLUTION FOR THIS DECREASE IN 4 EYES, AN ADDITIONAL SURGERY WHICH REPOSITIONED THE TUBE FROM THE ANTERIOR CHAMBER TO THE VITREOUS CAVITY WAS PERFORMED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. THIS REPORT IS FOR THE MODEL BG103-250. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER TWO MODELS BG102-350 & BG101-350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965260 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. BG103-250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention