BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 9084962 · Received September 18, 2019

    Report

    Report Number
    9614546-2019-00877
    Event Type
    Injury
    Date Received
    September 18, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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

    AGE/DATE OF BIRTH: EXACT AGE NOT PROVIDED, MEAN AGE WAS 67.7-68.6 YEARS. DATE OF EVENT: UNKNOWN. MODEL NUMBER: COMPLETE MODEL IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. THE ARTICLE ONLY PROVIDES BAERVELDT 350. CATALOG NUMBER: CATALOG NUMBER IS UNKNOWN. EXPIRATION DATE: UNKNOWN. SERIAL NUMBER: UNKNOWN. UDI NUMBER: UNKNOWN. IF IMPLANTED; GIVE DATE: UNKNOWN. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE) THERE IS NO INDICATION THE DEVICE HAS BEEN EXPLANTED. 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. (B)(4). ROTHMAN, A., AN, S., HERNDON JR, L. (2018). EFFECT OF SUTURE WICK TECHNIQUE ON EARLY INTRAOCULAR PRESSURE CONTROL AFTER NONVALVED (BAERVELDT 350) GLAUCOMA DRAINAGE DEVICE SURGERY. GLAUCOMA JOURNAL 27(1), PP. 1145-1150. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    "THE EFFECT OF SUTURE WICK TECHNIQUE ON EARLY INTRAOCULAR PRESSURE CONTROL AFTER NONVALVED (BAERVELDT 350) GLAUCOMA DRAINAGE DEVICE SURGERY" LITERATURE WAS REVIEWED. THE PUBLICATION REPORTED PATIENTS IN 2 GROUPS. PATIENTS IN A GROUP WITHOUT A WICK: 7 PATIENTS DEVELOPED HYPOTONY, 2 OF WHICH HAD WOUND DEHISCENCE OR LEAK; 3 PATIENTS HAD WOUND DEHISCENCE WITHOUT HYPOTONY; 3 PATIENTS HAD HYPHEMA; ONE REQUIRED ADDITIONAL SURGERY (DOES NOT SPECIFY WHY OR WHAT SURGERY WAS PERFORMED); PATIENTS IN THE GROUP WITH A WICK: 8 DEVELOPED HYPOTONY; 1 WITH WOUND DEHISCENCE; ONE HYPHEMA; ONE ELEVATED IOP REQUIRING PARACENTESIS; 2 REQUIRED ADDITIONAL SURGERY (DOES NOT SPECIFY WHY OR WHAT SURGERY WAS PERFORMED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877904 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention