BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3903091 · Received June 30, 2014

    Report

    Report Number
    2029214-2014-00370
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    February 20, 2014
    Report Date
    June 2, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BEEN RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT.THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS:MODEL#: FA-71500-25 / LOT#: NOT REPORTED / DOM: N/A / EXP: N/A (QTY. 3).MODEL#: FA-71500-30 / LOT#: NOT REPORTED / DOM: N/A / EXP: N/A.(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ASPIRE PROSPECTIVE REGISTRY, SUBJECT (B)(4). TREATMENT OF A SMALL UNRUPTURED FUSIFORM ANEURYSM MEASURING 8MM LOCATED IN THE MIDLINE BASILAR ARTERY. THE PATIENT PRESENTED WITH NEUROLOGICAL SYMPTOMS OF DIZZINESS AND/OR LOSS OF BALANCE AND UNSTABLE WALKING WITHOUT HEMIPARESIS. THE PATIENT WAS GIVEN ANTICOAGULANT / ANTIPLATELET MEDICATION PRIOR TO THE PROCEDURE, AND ADMINISTERED HEPARIN INTRA-OPERATIVELY. ON (B)(6) 2013, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION INVOLVING 5 PIPELINES (5MM X 20MM; 5MM X 25MM, QTY. 3; 5MM X 30MM) WITHOUT ISSUES. ON (B)(6) 2014, THE PATIENT UNDERWENT EMBOLIZATION RE-TREATMENT WITH COILS FOR A RESIDUAL ANEURYSM AND DEVICE MIGRATION. POST PROCEDURAL ANGIOGRAM SHOWED A RESIDUAL ANEURYSM. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AND FURTHER INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381216 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-20 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 64 Required Intervention| S