BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAERVELDT SHUNT

    MDR report key: 8895674 · Received August 14, 2019

    Report

    Report Number
    9614546-2019-00733
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    AGES/DATE(S) OF BIRTH: UNKNOWN, NOT PROVIDED. GENDER(S)SEX(ES): UNKNOWN, NOT PROVIDED. DATE(S) OF EVENT: UNKNOWN, NOT PROVIDED. SERIAL NUMBER(S): UNKNOWN, NOT PROVIDED. CATALOG #(''S): COMPLETE CATALOG #''S ARE UNKNOWN AS SERIAL NUMBERS WERE NOT PROVIDED. UDI #(''S): UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED. EXPIRATION DATE(S): UNKNOWN AS THE SERIAL NUMBERS WERE NOT PROVIDED. IF IMPLANTED; GIVE DATE(S): UNKNOWN, NOT PROVIDED. IF EXPLANTED; GIVE DATE(S): UNKNOWN, NOT PROVIDED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBERS FOR THE DEVICES WERE 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(S): UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED. AUTHORS: ANNA C. MOMONT, MD, JOSHUA D. STEIN, MD, MS, PAUL P. LEE, MD, JD, JENNIFER S. WEIZER, MD. (2014). ARTICLE: SIMULTANEOUS PLACEMENT OF 2 GLAUCOMA DRAINAGE DEVICES FOR UNCONTROLLED GLAUCOMA. CITATION: CANADIAN J OPHTHALMOL, 49(2), PP.205-209 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ARTICLE: SIMULTANEOUS PLACEMENT OF 2 GLAUCOMA DRAINAGE DEVICES FOR UNCONTROLLED GLAUCOMA. AUTHORS: ANNA C. MOMONT, MD, JOSHUA D. STEIN, MD, MS, PAUL P. LEE, MD, JD, JENNIFER S. WEIZER, MD. PUBLICATION: CANADIAN J OPHTHALMOL 2014;49:205-209. OBJECTIVE: TO REPORT BASELINE CHARACTERISTICS AND SURGICAL OUTCOMES OF PLACEMENT OF SIMULTANEOUS GLAUCOMA DRAINAGE DEVICES (GDDS) IN EYES WITH CONSIDERABLY ELEVATED INTRAOCULAR PRESSURE (IOP) DESPITE MAXIMAL MEDICAL THERAPY. DESIGN: RETROSPECTIVE CASE SERIES. PARTICIPANTS: TWELVE EYES OF 12 PATIENTS UNDERWENT SIMULTANEOUS PLACEMENT OF A BAERVELDT 350 GDD AND AN AHMED S3 GDD IN THE SAME EYE. METHODS: THE MEDICAL RECORDS WERE REVIEWED OF CONSECUTIVE PATIENTS WHO UNDERWENT SIMULTANEOUS PLACEMENT OF A BAERVELDT 350 GDD AND AN AHMED S3 GDD IN THE SAME EYE AT THE UNIVERSITY OF MICHIGAN KELLOGG EYE CENTER FROM 2006 TO 2009. BASELINE CHARACTERISTICS, PREOPERATIVE AND POSTOPERATIVE IOP, NUMBER OF GLAUCOMA MEDICATIONS, VISUAL ACUITY, AND COMPLICATIONS WERE RECORDED. RESULTS: MEAN FOLLOW-UP TIME WAS 28.6 ± 22.8 MONTHS. THE MEAN BASELINE CUP/DISC RATIO WAS RECORDED AT 0.94 ± 0.07 HORIZONTALLY AND 0.92 ± 0.09 VERTICALLY. THE MEAN BASELINE IOP OF 38.8 ± 6.2 MM HG WAS SIGNIFICANTLY REDUCED AT ALL TIME POINTS POSTOPERATIVELY, AND THE MEAN IOP AT LAST FOLLOW-UP WAS 15.1 ± 4.9 MM HG (P R 0.0001). MEAN NUMBER OF GLAUCOMA MEDICATIONS WAS SIGNIFICANTLY LOWER AT LAST FOLLOW-UP THAN PREOPERATIVELY (1.4 ± 1.3 VS 3.2 ± 0.8; P ¼ 0.001). THERE WAS NO DIFFERENCE IN MEAN LOGMAR VISUAL ACUITY FROM BEFORE SURGERY TO LAST FOLLOW-UP (1.14 VS 1.12; P ¼ 0.933). CONCLUSIONS: SIMULTANEOUS PLACEMENT OF 2 GDDS EFFECTIVELY REDUCES IOP IN THE IMMEDIATE POSTOPERATIVE PERIOD AND LONG-TERM, AND MAY BE USEFUL IN GLAUCOMATOUS EYES WITH ADVANCED DISEASE AND CONSIDERABLY ELEVATED PREOPERATIVE IOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685304 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. BG101-350

    Patients

    Seq Age Sex Outcome Treatment
    1