BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 5435535 · Received February 12, 2016

    Report

    Report Number
    9614546-2016-00050
    Event Type
    Injury
    Date Received
    February 12, 2016
    Date of Event
    May 29, 2015
    Report Date
    September 19, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI#: NOT AVAILABLE SINCE PRODUCT SERIAL WAS NOT PROVIDED. SERIAL AND EXPIRATION DATE : NOT AVAILABLE SINCE PRODUCT SERIAL NUMBER WAS NOT PROVIDED. MFG DATE: NOT AVAILABLE SINCE PRODUCT SERIAL NUMBER WAS NOT PROVIDED. PUBLICATION - SCHAEFER JL, LEVINE MA, MARTORANA G, KOENIGSMAN H, FRAN SMITH M, SHERWOOD MB. FAILED GLAUCOMA DRAINAGE IMPLANT: LONGTERM OUTCOMES OF A SECOND GLAUCOMA DRAINAGE DEVICE VERSUS CYCLOPHOTOCOAGULATION. BR J OPHTHALMOL. 2015;99(12):1718-1724.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: IF IMPLANTED; GIVE DATE(S): SPECIFIC DATES UNKNOWN, BUT NOTED IN ARTICLE AS BETWEEN (B)(6) 1986 AND (B)(6) 2012. EXPLANT DATE: IF EXPLANTED; GIVE DATE: NA (NOT APPLICABLE) THERE WAS NO INFORMATION INDICATING THE SHUNTS WERE EXPLANTED. DEVICE EVALUATION: THE BAERVELDT SHUNTS WERE NOT RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. THEREFORE, PRODUCT INVESTIGATION WAS NOT POSSIBLE. THE REPORTED EVENTS COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS THE SERIAL NUMBERS WERE UNKNOWN, WERE NOT PROVIDED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. THE DFU INCLUDES A SECTION ON COMPLICATIONS/ADVERSE EVENTS FOR THE PRODUCT. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED COMPLAINT WAS NOT VERIFIED AND THERE IS NO INDICATION OF PRODUCT DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 OF 15 EYES HAD WORSENING OF A VISUAL ACUITY OF 2 SNELLEN LINES OR MORE AND 4 OF 15 EYES DEVELOPED CORNEAL DECOMPENSATION FOLLOWING IMPLANTATION OF THE BAERVELDT SHUNT. IT WAS ALSO REPORTED THAT 9 OF THE 15 EYES REQUIRED ADDITIONAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91140 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R