BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 4231977 · Received November 6, 2014

    Report

    Report Number
    9614546-2014-00266
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    June 5, 2014
    Report Date
    October 22, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: (B)(6). IN MDR FOLLOW UP #2: DATE RECEIVED BY MANUFACTURER HAS BEEN CORRECTED TO 03/03/2015. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION USING A MICROSCOPE AT 12X MAGNIFICATION SHOWS THE SHUNT CAN BE IDENTIFIED AS BAERVELDT GLAUCOMA IMPLANT MODEL BG101-350. THE TUBE IS TIED OFF WITH SUTURE. THE SHUNT WAS PREPARED FOR USE CORRESPONDING TO THE INFORMATION IN THE INITIAL REPORT. VISUAL INSPECTION OF THE RETURN SAMPLE DOES NOT SHOW NON-CONFORMANCES. THE INFORMATION AVAILABLE IN THE INITIAL REPORT DOES NOT INDICATE ANY RELATIONSHIP WITH THE SHUNT DESIGN OR MANUFACTURING. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. MANUFACTURING RECORDS WERE REVIEWED. THE DEVICE WAS PRODUCED ACCORDING TO PROCEDURES AND WITHOUT DEVIATIONS OR NON-CONFORMANCES. THERE WERE NO PROCESS AND/OR MATERIAL CHANGES. ENVIRONMENTAL AND STERILZATION RECORDS WERE WITHIN SPECIFICATION, THERE WERE NO NON-CONFORMING MATERIALS REPORTS. THE INFORMATION, ALTHOUGH LIMITED, DOES NOT INDICATE ANY RELATIONSHIP WITH THE DESIGN OR MANUFACTURING. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A BAERVELDT SHUNT WAS EXPLANTED BECAUSE THE TUBE WAS EXPOSED, THERE WAS A ''MELT AT THE PLATE'' AND IT WAS SLIGHTLY RAISED. THE DEVICE WAS REMOVED AND ANOTHER BAERVELDT (A 250) WAS IMPLANTED IN A DIFFERENT QUADRANT OF THE EYE. ON (B)(6) 2014 PATIENT'S IOP WAS STABLE AND THE PATIENT HAD RECOVERED FROM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714594 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS BG101-350

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention