BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 8895037 · Received August 14, 2019

    Report

    Report Number
    9614546-2019-00730
    Event Type
    Injury
    Date Received
    August 14, 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
    IL, 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: AGE RANGE BETWEEN 20-85 YEARS OF AGE. SEX/GENDER: MALE AND FEMALE, MAJORITY BEING MALE. DATE OF EVENT: UNKNOWN. CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN. EXPIRATION DATE: UNKNOWN. SERIAL NUMBER: UNKNOWN. UDI NUMBER: UNKNOWN. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE) UNKNOWN. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE) UNKNOWN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT/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). NAMAVARI, A., HYDE, R., WANG, D., VAJARANANT, T., AREF A. P. (2016). PRIMARY BAERVELDT SHUNT IMPLANTATION: OUTCOMES AND COMPLICATIONS. OPHTHALMOL THER 5(1), PP. 253-262. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE "PRIMARY BAERVELDT SHUNT IMPLANTATION: OUTCOMES AND COMPLICATIONS" LITERATURE WAS REVIEWED. AUTHORS: ABED NAMAVARI, ROBERT HYDE, DANIEL WANG, THASARAT VAJARANANT. PUBLICATION: OPHTHALMOL THER (2016). 5: 253-262. PATIENTS WHO UNDERWENT 350-MM2 BAERVELDT GLAUCOMA IMPLANT (BGI) THROUGH THE GLAUCOMA SERVICE OF THE UNIVERSITY OF ILLINOIS AT CHICAGO BETWEEN 2010 AND 2015 WERE INCLUDED IN THIS STUDY. OUTCOME MEASURES INCLUDED AGE, SEX, ETHNICITY, OPERATED EYE, PREOPERATIVE DIAGNOSIS, PREOPERATIVE, AND SEQUENTIAL POSTOPERATIVE INTRAOCULAR PRESSURE (IOP), VISUAL ACUITY, GLAUCOMA MEDICATIONS, AND POSTOPERATIVE COMPLICATION AND INTERVENTIONS. STATISTICAL ANALYSES WERE PERFORMED USING THE TWO-SIDED STUDENT T TEST FOR CONTINUOUS VARIABLES. THIRTY-SEVEN PATIENTS WERE STUDIED. IOP WAS CONSISTENTLY AND STATISTICALLY SIGNIFICANTLY LOWER AT 3 MONTHS (17.4 ± 6.4, P = 3 9 10-7), 6 MONTHS (13.9 ± 5.1, P = 2 9 10-11), 1 YEAR (12.2 ± 4.0, P = 9 9 10-10), AND 2 YEARS (14.6 ± 3.3, P = 0.0004) POSTOPERATIVELY COMPARED TO IOP AT BASELINE (27.5 ± 8.1). FEWER GLAUCOMA MEDICATIONS WERE USED AT 3 MONTHS (2.8 ± 1.3, P = 0.04), 6 MONTHS (2.6 ± 1.2, P = 0.02), 1 YEAR (2.7 ± 1.7, P = 0.04), AND 2 YEARS (2.0 ± 1.2, P = 0.03) POSTOPERATIVELY COMPARED TO BASELINE (3.4 ± 1.1). A TOTAL OF SIX CASES (16%) HAD FAILURE. A TOTAL OF FIVE PATIENTS (15%) HAD POSTOPERATIVE COMPLICATIONS. MEAN SNELLEN VISUAL ACUITY WAS NOT STATISTICALLY DIFFERENT AT 6 MONTHS (0.5 ± 0.6, P = 0.88) OR 1 YEAR (0.4 ± 0.4, P = 0.57) POSTOPERATIVELY FROM BASELINE (0.5 ± 0.6). A TOTAL OF FIVE PATIENTS (15%) EXPERIENCED POSTOPERATIVE COMPLICATIONS. ONE PATIENT REQUIRED REOPERATION TO TREAT THE COMPLICATION. ONE ADDITIONAL PATIENT REQUIRED REFORMING OF ANTERIOR CHAMBER WITH VISCOELASTIC DUE TO SHALLOW ANTERIOR CHAMBER NOTED POSTOPERATIVELY. THE TREATMENT OUTCOME FOR THIS PATIENT WAS CONSIDERED A QUALIFIED SUCCESS. MEAN SNELLEN VA ± STANDARD DEVIATION AT BASELINE, 6 MONTHS POSTOPERATIVELY, AND 1 YEAR POSTOPERATIVELY WERE 0.5 ± 0.6, 0.5 ± 0.6, AND 0.4 ± 0.4, RESPECTIVELY. MEAN SNELLEN VA WAS NOT STATISTICALLY DIFFERENT AT 6 MONTHS OR 1 YEAR POSTOPERATIVELY FROM BASELINE (P = 0.88 AND P = 0.57, RESPECTIVELY). A TOTAL OF FOUR PATIENTS (10%) HAD PROGRESSION OF CATARACT. THERE WERE A TOTAL OF FIVE POSTOPERATIVE COMPLICATIONS IN THIS STUDY, INCLUDING ANTERIOR CHAMBER SHALLOWING, HYPHEMA, CHRONIC IRITIS, PERSISTENT CHOROIDAL EFFUSION, AND RHEGMATOGENOUS RETINAL DETACHMENT. THE OVERALL RATE OF POSTOPERATIVE COMPLICATIONS WAS 15%, SIMILAR TO THAT SEEN IN A RECENT STUDY OF PATIENTS UNDERGOING PRIMARY BGI [4]. WHILE THAT STUDY INCLUDED PERSISTENT CORNEAL EDEMA, BLEB LEAK, AND PERSISTENT DIPLOPIA AS POSTOPERATIVE COMPLICATIONS IN THE BGI GROUP, IN THIS STUDY THERE WERE NO PATIENTS WITH THOSE COMPLICATIONS. IN SUMMARY, THIS STUDY WILL HELP PROVIDE EVIDENCE-BASED INFORMATION THAT WILL ASSIST IN SURGICAL DECISION MAKING FOR PATIENTS REQUIRING A PRIMARY PROCEDURE TO MANAGE GLAUCOMA. PRIMARY BGI IS EFFECTIVE AT REDUCING IOP AT 6 MONTHS, SIGNIFICANTLY DECREASES THE MEDICATION BURDEN, AND IS ASSOCIATED WITH RELATIVELY SIMILAR POST-OPERATIVE AND VISUAL ACUITY COMPLICATIONS AT 1 YEAR COMPARED TO RESULTS SEEN IN OTHER STUDIES, REGARDLESS OF PRIOR INCISIONAL OCULAR SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686839 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. BG101-350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention