BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 10519271 · Received September 10, 2020

    Report

    Report Number
    9614546-2020-00397
    Event Type
    Injury
    Date Received
    September 10, 2020
    Report Date
    September 10, 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 · 1

    AGES/DATE(S) OF BIRTH: MEAN AGE FROM 2005 TO 2006: 68 YR & FROM 2015-2016: 67.2 YR GENDER(S)SEX(ES): FROM 2005 TO 2006: 61% FEMALE, 39% MALE & FROM 2015-2016: 58% FEMALE, 42% MALE. DATE(S) OF EVENT: UNKNOWN, NOT PROVIDED. MODEL #: UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED CATALOG#: THE CATALOG NUMBER IS UNKNOWN AS SERIAL NUMBERS WERE 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. 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: KNIER, G.C., BS, WANG, F., MD, BARATZ, K., MD, KHANNA, L.C., MD, (2019). GLAUCOMA DRAINAGE DEVICES AND REASONS FOR KERATOPLASTY. J GLAUCOMA, 28(10), PP. 906¿910. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: GLAUCOMA DRAINAGE DEVICES AND REASONS FOR KERATOPLASTY. A RETROSPECTIVE STUDY WAS DONE TO WAS TO DETERMINE WHETHER THE REASONS FOR KERATOPLASTY HAVE CHANGED BETWEEN 10 YEARS IN A TERTIARY CARE SETTING, WITH SPECIAL ATTENTION TO THE RATE OF GLAUCOMA DRAINAGE DEVICES (GDDS) AS A REASON FOR KERATOPLASTY. THEY REPORTED A TOTAL OF 10 EYES WITH BAERVELDT IMPLANTS WHICH HAD TO UNDERGO KERATOPLASTY PROCEDURES DUE TO CORNEAL DECOMPENSATION ATTRIBUTABLE TO GDD IMPLANTATION. OTHER COMPLICATIONS REPORTED IN THE STUDY INCLUDED INFECTION, PSEUDOPHAKIC BULLOUS KERATOPATHY (PBK), UVEITIS, TRAUMA, ENDOPHTHALMITIS, ANGLE-CLOSURE, HYPOTONY, AND CONGENITAL GLAUCOMA. IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN EYES WITH THE BAERVELDT GLAUCOMA IMPLANTS OR THE OTHER PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981063 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention