BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 6130988 · Received November 29, 2016

    Report

    Report Number
    2029214-2016-01071
    Event Type
    Death
    Date Received
    November 29, 2016
    Date of Event
    June 2, 2016
    Report Date
    November 1, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 EVENT OCCURRED IN THE PATIENT POST-PROCEDURE AND ITS CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. BURROWS, A. M. ET AL. (2016, JUNE 02). FLOW DIVERSION FOR OPHTHALMIC ARTERY ANEURYSMS. AMERICAN JOURNAL OF NEURORADIOLOGY, 37(10), 1866-1869. MDRS RELATED TO THIS ARTICLE: 2029214-2016-01070 2029214-2016-01071.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM LITERATURE THAT A PATIENT DIED AFTER FLOW DIVERSION TREATMENT. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE OUTCOMES OF PATIENTS WITH CAROTID-OPHTHALMIC ANEURYSMS TREATED WITH FLOW DIVERSION. THE ARTICLE EVALUATED 50 CAROTID-OPHTHALMIC ANEURYSMS IN 48 PATIENTS; 46 OF THE ANEURYSMS IN 44 PATIENTS RECEIVED TREATMENT. FORTY FIVE OF THE ANEURYSMS WERE TREATED WITH THE PIPELINE EMBOLIZATION DEVICE (PED) AND 1 ANEURYSM WAS TREATED WITH ANOTHER MANUFACTURER¿S DEVICE. MEAN AGE WAS 52 YEARS; 41 OF THE ANEURYSMS WERE FOUND IN WOMEN. THE AUTHORS STATED THAT AT 12 DAYS POST-IMPLANTATION, ONE PATIENT WITH A 21MM ANEURYSM DIED OF A DELAYED DISTAL INTRAPARENCHYMAL HEMORRHAGE NOT RELATED TO ANEURYSM RUPTURE. THE AUTHORS STATED THIS DEATH WAS PROCEDURE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782309 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death