BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 10536263 · Received September 15, 2020

    Report

    Report Number
    9614546-2020-00404
    Event Type
    Injury
    Date Received
    September 15, 2020
    Report Date
    September 15, 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
    AP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. SERIAL NUMBER: UNKNOWN/NOT PROVIDED. CATALOG#: PARTIAL CATALOG NUMBER UNKNOWN, INCOMPLETE MODEL NUMBER ONLY 350 PROVIDED. MODEL#: PARTIAL MODEL NUMBER UNKNOWN, INCOMPLETE MODEL NUMBER ONLY 350 PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. (B)(4). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: THE COMPLAINT HISTORY WAS NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. 2019 ASIA-PACIFIC JOURNAL OF OPHTHALMOLOGY VOLUME 8, NUMBER 6, PP. 489¿500, NOVEMBER/DECEMBER 2019. SUPPLEMENTAL MATERIAL AVAILABLE AT HTTPS://JOURNALS.LWW.COM/APJOO. 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: ARTICLE: ATTAINING INTRAOCULAR PRESSURE OF <=10 MM HG: COMPARISON OF TUBE AND TRABECULECTOMY SURGERY IN PSEUDOPHAKIC PRIMARY GLAUCOMA EYES A RETROSPECTIVE, NONRANDOMIZED STUDY WAS DONE TO EVALUATE WHETHER TRABECULECTOMY WITH ANTIMETABOLITES OR GLAUCOMA DRAINAGE DEVICE (GDD) SURGERY IS MORE LIKELY TO ACHIEVE AN INTRAOCULAR PRESSURE (IOP) =10 MM HG. OF THE 65 EYES THAT HAD GDD PROCEDURE, 48 EYES RECEIVED BAERVELDT IMPLANT (N=43 ON BGI 350MM AND N=5 ON BGI 250MM). ON POST-OP 1 YEAR, 2 YEAR, 3 YEAR, 4 YEAR AND 5 YEAR, THE NUMBER OF EYES LOSING = 2 SNELLEN LINES IN THE GDD GROUP WERE 16, 15, 16, 10, AND 7 RESPECTIVELY. EARLY POSTOPERATIVE COMPLICATIONS REPORTED IN THE STUDY INCLUDED CHOROIDAL EFFUSION (N=8), BLEB LEAK (N=1), HYPHEMA (N=3) AND ONE PATIENT NEEDED SURGICALLY ADDED VENTING SLITS (N=1). FOUR (4) OF THE PATIENTS WHO EXPERIENCED CHOROIDAL EFFUSION REQUIRED A VISCOELASTIC TO THE ANTERIOR CHAMBER. LATE POSTOPERATIVE COMPLICATIONS REPORTED IN THE STUDY INCLUDED CHOROIDAL EFFUSION (N=3), TUBE EXPOSURE (N=1), AND CYSTOID MACULAR EDEMA (N=1). FIVE GDD EYES UNDERWENT EITHER PENETRATING KERATOPLASTY OR DESCEMET STRIPPING ENDOTHELIAL KERATOPLASTY DUE TO CORNEAL DECOMPENSATION (N=5). FOR INADEQUATE CONTROL OF INTRAOCULAR PRESSURE (IOP) (N=7), SIX PATIENTS UNDERWENT DIODE CYCLOPHOTOCOAGULATION (N=6) AND ONE PATIENT UNDERWENT ADDITIONAL GDD IMPLANTATION (N=1). IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN EYES WITH THE BAERVELDT GLAUCOMA IMPLANTS OR THE OTHER PRODUCT. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999903 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention