BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3140651 · Received May 31, 2013

    Report

    Report Number
    2029214-2013-00512
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    March 1, 2012
    Report Date
    May 13, 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

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(4) CLINICAL DATABASE. TREATMENT OF A MIDLINE UNRUPTURED BASILAR SIDEWALL SACCULAR ANEURYSM MEASURING 23MM X 13MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING A TOTAL OF FOUR PIPELINES AND SOME COILS ON TWO DIFFERENT DATES DUE TO THE VISIBILITY AND TORTUOSITY AND THE PATIENT REMAINED NEUROTICALLY BASELINE AFTER THE PROCEDURES; HOWEVER, SHE EXPERIENCED INCREASED HEADACHES ACCOMPANIED BY NAUSEA ON (B)(6) 2012. THE PATIENT HAD RETREATMENT FOR THE INDEX ANEURYSM WITH TWO PIPELINES ON (B)(6) 2012. NO OTHER INJURIES WERE REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2013-00513 / 2029214-2013-00514 / 2029214-2013-00515.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242261 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71425-35 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Disability