BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2990461 · Received March 5, 2013

    Report

    Report Number
    2029214-2013-00169
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    April 16, 2012
    Report Date
    February 7, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT.THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS:MODEL: FA-71375-35 / LOT: NOT REPORTED / DOM: N/A / EXP: N/AMODEL: FA-71375-30 / LOT: NOT REPORTED / DOM: N/A / EXP: N/AMODEL: FA-71375-25 / LOT: NOT REPORTED / DOM: N/A / EXP: N/AMODEL: FA-71400-35 / LOT: NOT REPORTED / DOM: N/A / EXP: N/AMODEL: FA-71425-30 / LOT: NOT REPORTED / DOM: N/A / EXP: N/AMODEL: FA-71425-25 / LOT: NOT REPORTED / DOM: N/A / EXP: N/AMODEL: FA-77425-20 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (QTY 2)MODEL: FA-71450-35 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (QTY 2)MODEL: FA-71400-30 / LOT: NOT REPORTED / DOM: N/A / EXP: N/AMODEL: FA-71450-25 / LOT: NOT REPORTED / DOM: N/A / EXP: N/AMODEL: FA-71475-35 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(4) CLINICAL DATABASE. TREATMENT OF A RIGHT UNRUPTURED FUSIFORM ICA (INTERNAL CAROTID ARTERY) SIDEWALL ANEURYSM MEASURING 32MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2011 INVOLVING ELEVEN PIPELINES AND THEN HAD TWO MORE PIPELINES IMPLANTED ON (B)(6) 2011 FOR ADDITIONAL COVERAGE. APPROXIMATELY FIVE MONTHS AFTER THE PROCEDURE, THE PATIENT HAD AN INCREASE IN PRE-PROCEDURE SYMPTOMS. AN ANGIOGRAM IN (B)(6) 2012 REVEALED PERSISTENT FILLING IN TWO PLACES; THEREFORE, PLAVIX WAS DISCONTINUED AND ASA (ACETYLSALICYLIC ACID) REMAINED THE SAME. ANOTHER ANGIOGRAM WAS PERFORMED IN (B)(6) 2012 DUE TO THE SAME INCREASING SYMPTOMS AND IT SHOWED A THROMBOSIS OF THE RIGHT ICA (INTERNAL CAROTID ARTERY) WITHOUT A STROKE. IT WAS REPORTED THAT THE PATIENT'S ISSUES RESOLVED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93847 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71375-35 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Disability