BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 5992504 · Received October 1, 2016

    Report

    Report Number
    2029214-2016-00853
    Event Type
    Injury
    Date Received
    October 1, 2016
    Date of Event
    April 4, 2014
    Report Date
    September 14, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON THE REPORTED INFORMATION. MDRS RELATED TO THIS PATIENT: 2029214-2016-00437 2029214-2016-00852 2029214-2016-00853 2029214-2016-00854. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A CLINICAL STUDY THAT A PATIENT EXPERIENCED STENOSIS (75-100%) AND PARENT ARTERY OCCLUSION AFTER PIPELINE IMPLANTATION. THIS INFORMATION WAS RECEIVED FROM REVIEW OF THE PATIENT'S FIVE-YEAR FOLLOW-UP IMAGING. THERE WERE NO REPORTS OF PATIENT SYMPTOMS IN RELATION TO THIS EVENT. THE PATIENT ALSO UNDERWENT A FIVE-YEAR NEUROLOGIC EXAM, WHICH SHOWED THAT THE PATIENT'S NEUROLOGICAL FUNCTIONS WERE THE SAME OR BETTER THAN BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643961 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-77350-10 MY08-038

    Patients

    Seq Age Sex Outcome Treatment
    1 Other