BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 9074175 · Received September 17, 2019

    Report

    Report Number
    9614546-2019-00869
    Event Type
    Injury
    Date Received
    September 17, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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/DATES OF BIRTH: UNKNOWN, NOT PROVIDED. GENDERS/SEXES: UNKNOWN, NOT PROVIDED. DATES OF EVENT: UNKNOWN, NOT PROVIDED. EXPIRATION DATES: UNKNOWN, AS THE SERIAL NUMBERS WERE NOT PROVIDED. SERIAL NUMBERS: UNKNOWN, INFORMATION NOT PROVIDED. UDI NUMBERS: UNKNOWN, AS THE SERIAL NUMBERS WERE NOT PROVIDED. CATALOG NUMBERS: COMPLETE CATALOG NUMBERS ARE UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED. IF IMPLANTED; GIVE DATES: UNKNOWN, NOT PROVIDED. IF EXPLANTED; GIVE DATES: UNKNOWN, NOT PROVIDED. TELEPHONE NUMBER: UNKNOWN, NOT PROVIDED. DEVICE MANUFACTURE DATES: UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED. (B)(4). DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    LITERATURE TITLE: HYPERTENSIVE PHASE AND ITS ASSOCIATION WITH SURGICAL OUTCOMES IN BAERVELDT IMPLANTATION. AUTHORS: SUNEE CHANSANGPETCH, SUPAWAN SURUKRATTANASKUL, PANEEYA TAPANEEYANGKUL, VISANEE TANTISEVI. INT OPHTHALMOL. DOI: 10.1007/S10792-017-0654-8. THE PUBLICATION REPORTED EARLY POST OPERATIVE (WITHIN 3 MONTHS) COMPLICATIONS INCLUDED: SHALLOW ANTERIOR CHAMBER: 7; CHOROIDAL DETACHMENT: 6; EXPOSED TUBE: 1; WOUND LEAK: 1; HYPHEMA: 1; VITREOUS HAEMORRHAGE: 1; PRESUMED ENDOPHTHALMITIS: 1; EXPOSED PLATE: 1. LATE POST OPERATIVE COMPLICATIONS (AFTER 3 MONTHS) INCLUDED: PERSISTENT CORNEAL EDEMA: 7; FLAT ANTERIOR CHAMBER: 2; CHOROIDAL DETACHMENT: 2; EXPOSED TUBE: 1; HYPHEMA: 1; HYPOTONY: 1; RETINAL DETACHMENT: 1. THE 2 PATIENTS WITH EXPOSED TUBE, ONE WITH EXPOSED PLATE, AND 1 WITH RECURRENT HYPHEMA ALL REQUIRED FOLLOW UP SURGERY; 3 OF WHICH LOST VISION TO NO LIGHT PERCEPTION. 16 PATIENTS REQUIRED ADDITIONAL TOPICAL ANTI-GLAUCOMA DRUGS POST SURGERY WHICH WERE SUBSEQUENTLY TAILORED OFF; HOWEVER, 4 OF THE 16 COULD NOT BE TAPERED OFF AND CONTINUED TO NEED 3 OR MORE MEDICATIONS TO CONTROL THE IOP (INTRAOCULAR PRESSURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871696 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. BG102-350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention