BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 8872133 · Received August 7, 2019

    Report

    Report Number
    9614546-2019-00701
    Event Type
    Injury
    Date Received
    August 7, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    LONG-TERM EFFICACY OF THE BAERVELDT 250 MM2 COMPARED WITH THE BAERVELDT 350 MM2 IMPLANT. AUTHORS: EVAN J. ALLAN, MD, MAHMOUD A. KHAIMI, MD, JOSHUA M. JONES, BS, KAI DING, PHD, GREGORY L. SKUTA, MD. AGES/DATE OF BIRTH: UNKNOWN. GENDER SEX: UNKNOWN. DATE OF EVENT: UNKNOWN. SERIAL NUMBER: UNKNOWN. CATALOG NO:COMPLETE CATALOG NO ARE UNKNOWN. UDI NO: UNKNOWN. EXPIRATION DATE: UNKNOWN. IF IMPLANTED; GIVE DATE: UNKNOWN. IF EXPLANTED; GIVE DATE: UNKNOWN. 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: UNKNOWN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    LONG-TERM EFFICACY OF THE BAERVELDT 250 MM2 COMPARED WITH THE BAERVELDT 350 MM2 IMPLANT. EVAN J. ALLAN, MD, MAHMOUD A. KHAIMI, MD, JOSHUA M. JONES, BS, KAI DING, PHD, GREGORY L. SKUTA, MD PUBLICATION: OPHTHALMOLOGY 2015 122 486-493 2015 BY THE AMERICAN ACADEMY OF OPHTHALMOLOGY. PURPOSE: TO INVESTIGATE THE LONG-TERM SURGICAL OUTCOMES OF THE BAERVELDT 250 MM2 VERSUS BAERVELDT 350 MM2 GLAUCOMA DRAINAGE IMPLANTS (GDIS) (ABBOTT LABORATORIES INC, ABBOTT PARK, IL) IN THE TREATMENT OF REFRACTORY GLAUCOMA. DESIGN: COMPARATIVE CASE STUDY. PARTICIPANTS: A TOTAL OF 89 CONSECUTIVE EYES IN 86 PATIENTS TREATED AT DEAN MCGEE EYE INSTITUTE BETWEEN JANUARY 2006 AND DECEMBER 2008. METHODS: WE RETROSPECTIVELY REVIEWED PATIENT DATA FROM THE FOLLOWING POSTOPERATIVE VISITS: 1 WEEK, 1 MONTH, 2 MONTHS, 3 MONTHS, 6 MONTHS, AND EVERY 3 MONTHS THEREAFTER. POSTOPERATIVE COMPLICATIONS WERE ALSO RECORDED. THE MEAN FOLLOW-UP TIME WAS 40 MONTHS (RANGE, 2-78 MONTHS) FOR THE BAERVELDT 250 MM2 GROUP AND 31 MONTHS (RANGE, 3-75 MONTHS) FOR THE BAERVELDT 350 MM2 GROUP. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME MEASURE WAS SURGICAL SUCCESS. SECONDARY OUTCOME MEASURES INCLUDED VISUAL ACUITY (VA), INTRAOCULAR PRESSURE (IOP), AND NUMBER OF MEDICATIONS. RESULTS: THERE WAS NO DIFFERENCE IN SURGICAL SUCCESS (P 0.98). NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN VA MEASURED USING THE LOGARITHM OF THE MINIMUM ANGLE OF RESOLUTION (LOGMAR) SCALE, IOP, AND NUMBER OF MEDICATIONS AT THE LAST VISIT (P 0.09, 0.23, AND 0.82, RESPECTIVELY). COMPLICATION AND FAILURE RATES WERE COMPARABLE (P 0.82 AND 0.64, RESPECTIVELY). CONCLUSIONS: WITH A MEAN FOLLOW-UP OF 40 AND 31 MONTHS, NO DIFFERENCES IN SURGICAL SUCCESS, VA, IOP, NUMBER OF MEDICATIONS AT THE LAST VISIT, AND COMPLICATION/FAILURE RATES WERE NOTED BETWEEN THE BAERVELDT 250 MM2 AND 350 MM2 GDIS, RESPECTIVELY. THE SIZE OF THE GDI MAY NOT BE ASSOCIATED WITH SURGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663557 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. BG101-350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R