BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3000507 · Received March 12, 2013

    Report

    Report Number
    2029214-2013-00173
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    November 25, 2010
    Report Date
    February 18, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE INTREPED CLINICAL DATABASE. TREATMENT OF A LEFT UNRUPTURED ICA (INTERNAL CAROTID ARTERY) SIDEWALL ANEURYSM MEASURING 22MM X 7MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING TWO OVERLAPPING PIPELINES ON (B)(6) 2010 AND HER VISUAL ACUITY DECREASED ON (B)(6) 2010 DUE TO A THROMBOSIS OF THE TARGET ANEURYSM. THE PATIENT ALSO HAD A DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) ON (B)(6) 2011 FOLLOWED BY TRANSIENT LEFT HEMIPARESIS AND A PSYCHOTIC EPISODE. SHE HAD MALIGNANT NEUROLEPTIC SYNDROME AND WAS TRANSFERRED TO ICU FOLLOWING MEDICATION. IT WAS REPORTED THAT THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2012

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103970 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-18 (QTY 2) NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability