BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 6737531 · Received July 24, 2017

    Report

    Report Number
    9614546-2017-00658
    Event Type
    Injury
    Date Received
    July 24, 2017
    Report Date
    September 26, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - (B)(6) 2017. UDI# UNKNOWN WAS LISTED, SINCE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. (B)(4). JOURNAL CITATION: ESTHER LEE KIM, JEFFREY TRAN, MARC TÖTEBERG-HARMS, ET AL., ¿VISION LOSS AND RECOVERY AFTER BAERVELDT AQUEOUS TUBE SHUNT IMPLANTATION,¿ JOURNAL OF OPHTHALMOLOGY, VOL. 2017, ARTICLE ID 4140305, 12 PAGES, 2017. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF THE FILE IT WAS OBSERVED THAT A CONCLUSION CODE WAS NOT INCLUDED IN SUPPLEMENTAL REPORT #1. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURING SITE. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    FROM THE JOURNAL OF OPHTHALMOLOGY TITLE: VISION LOSS AND RECOVERY AFTER BAERVELDT AQUEOUS TUBE SHUNT IMPLANTATION. ABSTRACT: THIS STUDY AIMS TO DETERMINE THE COURSE OF VISION LOSS AFTER BAERVELDT AQUEOUS TUBE SHUNT PLACEMENT AND IDENTIFY RISK FACTORS ASSOCIATED WITH UNEXPLAINED SEVERE LONG-TERM VISION LOSS, OR SNUFF-OUT. WE RETROSPECTIVELY REVIEWED 247 EYES OF 222 PATIENTS WHO UNDERWENT BAERVELDT IMPLANTATIONS AT ONE OF TWO ACADEMIC INSTITUTIONS. POSTOPERATIVE VISION LOSS AT 6 MONTHS FOLLOWING SURGERY WAS CATEGORIZED AS MILD-TO-MODERATE VERSUS SEVERE AND LONG-TERM VERSUS TRANSIENT. LONG-TERM VISION LOSS, DEFINED AS 3 OR MORE LINES OF SNELLEN VISUAL ACUITY (VA) LOSS COMPARED WITH PREOPERATIVE VA, OCCURRED IN 63 OF 247 EYES (25.5%), AND 39 HAD MILD-TO-MODERATE AND 24 HAD SEVERE LOSS. OF THESE 63 EYES, 18 HAD NO IDENTIFIABLE CAUSE OF VISION LOSS. ON MULTIVARIATE ANALYSIS, POORER SNELLEN VA ON POSTOPERATIVE DAY 1 (POD1) WAS FOUND TO BE A SIGNIFICANT RISK FACTOR FOR LONG-TERM VISION LOSS (P = 0.005). IN ADDITION, THE NEGATIVE CHANGE IN PREOPERATIVE VERSUS POD1 SNELLEN VA (P = 0.021) AND THE PRESENCE OF SPLIT FIXATION INVOLVING THE INFERONASAL QUADRANT ON PREOPERATIVE HUMPHREY VISUAL FIELD (P = 0.044) WERE SIGNIFICANT RISK FACTORS FOR SNUFF-OUT. TRANSIENT VISION LOSS OCCURRED IN 76 OF 242 EYES (30.8%). IN CONCLUSION, VISION LOSS IS NOT UNCOMMON AFTER BAERVELDT SURGERY, WITH SNUFF-OUT OCCURRING IN 2.4% OF CASES IN THIS STUDY; 108 OF 247 EYES MAINTAINED VISION WITHIN TWO SNELLEN LINES OVER THE 6-MONTH POSTOPERATIVE PERIOD. 76 OF 247 EYES HAD TRANSIENT VISION LOSS: 41 EYES HAD MILD-TO-MODERATE VISION LOSS (3¿5 LINES OF SNELLEN VA LOSS FROM BASELINE). 35 EYES HAD SEVERE LOSS (>5 LINES OF SNELLEN VA). 63 OF 247 EYES HAD LONG-TERM VISION LOSS: 39 EYES HAD MILD-TO-MODERATE, 24 EYES HAD SEVERE LOSS. OTHER COMPLICATIONS REPORTED WERE GLAOCUMA, UVEITIS AND CORNEAL EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517068 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS BG101-350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other