BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 2725039 · Received September 4, 2012

    Report

    Report Number
    2020664-2012-00059
    Event Type
    Injury
    Date Received
    September 4, 2012
    Report Date
    August 7, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE: (B)(4). - BAERVELDT SHUNT. PMA K955455. (B)(4) - TO DATE, THE SHUNT REMAINS IMPLANTED. PRIOR TO RELEASE TO MARKET, THE SHUNT MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS (AMO) HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANT OF A SHUNT. POST OPERATIVELY, BETWEEN THE THREE (3) AND SIX (6) MONTHS INTERVAL, THE PATIENT WAS DIAGNOSED WITH CORNEAL ENDOTHELIAL DYSFUNCTION AND CYSTOID MACULAR EDEMA (CME). THE PATIENT RECEIVED AN INJECTION OF KENACORT INTO THE TENON'S CAPSULE FOR THE CME. ON (B)(6) 2012, THE PATIENT RECOVERED FROM THE EVENTS WITH SEQUELAE. THE DOCTOR COMMENTED THAT THE DEVICE HAD GOOD RESPONSE TO THE INTRAOCULAR PRESSURE (IOP) CONTROL; HOWEVER, THERE WERE POSTOPERATIVE COMPLICATIONS. THE PATIENT IS SCHEDULED TO HAVE A CORNEAL TRANSPLANT FOR THE CME. THE DOCTOR STATED THAT THE EVENTS WERE NOT ATTRIBUTED TO A DEVICE MALFUNCTION. HOWEVER, THE DOCTOR IS ATTRIBUTING THE EVENT TO POST OPERATIVE COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R