BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 5935090 · Received September 8, 2016

    Report

    Report Number
    9614546-2016-00442
    Event Type
    Injury
    Date Received
    September 8, 2016
    Report Date
    November 21, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    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 · 1

    (B)(6). (B)(4). CITATION: NAMAVARI A, HYDE RA, WANG D, VAJARANANT TS, AREF AA. PRIMARY BAERVELDT SHUNT IMPLANTATION: OUTCOMES AND COMPLICATIONS. OPHTHALMOLOGY AND THERAPY. 2016. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED, THEREFORE THE REPORTED COMPLAINT COULD NOT BE VERIFIED. THE MANUFACTURING RECORD COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. THE LABELING REVIEW WAS COMPLETED AND REVEALED THAT THE DIRECTIONS FOR USE (DFU) PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. NO LABELING CHANGES ARE REQUIRED. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ABSTRACT (ENGLISH): INTRODUCTION: THIS STUDY IS A RETROSPECTIVE CASE SERIES TO EVALUATE THE OUTCOMES AND COMPLICATIONS OF BAERVELDT GLAUCOMA IMPLANT SURGERY (BGI) IN PATIENTS WITHOUT PRIOR CATARACT OR INCISIONAL GLAUCOMA SURGERY. METHODS: PATIENTS WHO UNDERWENT 350-MM(2) BGI THROUGH THE (B)(6) 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. RESULTS: THIRTY-SEVEN PATIENTS WERE STUDIED. IOP WAS CONSISTENTLY AND STATISTICALLY SIGNIFICANTLY LOWER AT 3 MONTHS (17.4 ± 6.4, P = 3 × 10(-7)), 6 MONTHS (13.9 ± 5.1, P = 2 × 10(-11)), 1 YEAR (12.2 ± 4.0, P = 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). CONCLUSIONS: PRIMARY BGI IS EFFECTIVE AT REDUCING IOP AND THE MEDICATION BURDEN IN PATIENTS SUFFERING GLAUCOMATOUS OPTIC NEUROPATHY. FURTHER RANDOMIZED PROSPECTIVE STUDIES ARE NEEDED TO COMPARE VARIOUS PROCEDURES IN THE PRIMARY SURGICAL MANAGEMENT OF PATIENTS WITH UNCONTROLLED GLAUCOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586775 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention