BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 10480729 · Received September 1, 2020

    Report

    Report Number
    9614546-2020-00359
    Event Type
    Injury
    Date Received
    September 1, 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 Location
    US
    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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: EXACT AGE NOT PROVIDED, MEAN AGE AT SECOND GLAUCOMA DRAINAGE DEVICE IMPLANTATION WAS 72.46 ±13.94 YEARS. SEX/GENDER: MALE AND FEMALE. DATE OF EVENT: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, AS INFORMATION WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE) UNKNOWN/NOT PROVIDED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE) UNKNOWN/NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; 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 THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. BHAKTA, A., FORTUN, JORGE., THOMAS J., GREER, A., KISHOR, K., MAHARAJ, A. (2018). VISUALLY SIGNIFICANT CYSTOID MACULA EDEMA AFTER GLAUCOMA DRAINAGE IMPLANT SURGERY. GLAUCOMA JOURNAL 27(2), PP. 184-188. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: VISUALLY SIGNIFICANT CYSTOID MACULA EDEMA AFTER GLAUCOMA DRAINAGE IMPLANT SURGERY A RETROSPECTIVE STUDY WAS CONDUCTED TO EXAMINE THE INCIDENCE OF VISUALLY SIGNIFICANT CYSTOID MACULAR EDEMA (CME) POST GLAUCOMA DRAINAGE IMPLANT (GDI) SURGERY, AND TO ANALYZE RISK FACTORS ASSOCIATED WITH DEVELOPING CME AND PROGNOSIS WITH TREATMENT. POST-GDI COMPLICATIONS INCLUDED 41 EYES THAT DEVELOPED CME, 28 EYES DEVELOPED IRITIS, 55 EYES DEVELOPED EPIRETINAL MEMBRANE AND 24 EYES DEVELOPED HYPOTONY. CME WAS TREATED WITH EITHER TOPICAL OR INJECTABLE STEROIDS WHICH WERE VERY EFFECTIVE. ONE TREATMENT FOR CME WAS SPECIFIED AS TOPICAL PREDNISOLONE ACETATE 1% QID, KETOROLAC QID, AND ATROPINE 1% BID. THERE WERE ALSO 16 EYES THAT REPORTED TO HAVE CME RECURRENCE OF WHICH 10 EYES WERE TREATED WITH TOPICAL STEROID AND 6 EYES WERE TREATED WITH INJECTABLE STEROID BEFORE CME RECURRENCE. IT IS NOT CLEAR IF THE EVENTS OCCURRED WITH BAERVELDT GDI; NOR IS IT CLEAR IF THE ADVERSE EVENT IS DIRECTLY ATTRIBUTABLE TO THE GLAUCOMA IMPLANT; HOWEVER, IT WAS INDICATED THAT THE MAJORITY OF GDIS USED WERE BAERVELDT. FOLLOW-UP WAS CONDUCTED, FURTHER INFORMATION WAS PROVIDED AND IT WAS REPORTED THAT CME IS NOT DUE TO A PARTICULAR FAULTY PRODUCT, BUT RATHER GENERALIZED TO GLAUCOMA DRAINAGE IMPLANTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR MODEL BG103-250 ADVERSE EVENT. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE ADVERSE EVENT FOR THE UNKNOWN MODEL 350MM. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940463 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. BG103-250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention