BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 6042505 · Received October 19, 2016

    Report

    Report Number
    2029214-2016-00924
    Event Type
    Death
    Date Received
    October 19, 2016
    Date of Event
    September 24, 2016
    Report Date
    September 24, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE FLEX WILL NOT BE RETURNED AS IT WAS IMPLANTED IN THE PATIENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO BE ANY DEVICE DURING IMPLANTATION. THE EVENT OCCURRED IN THE PATIENT POST-PROCEDURE AND AN EVENT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    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 REPORT THAT A PATIENT EXPERIENCED INTRAPARENCHYMAL HEMORRHAGE FOUR DAYS AFTER PIPELINE FLEX IMPLANTATION. THE PATIENT HAD RECEIVED THE PIPELINE FLEX TO TREAT AN UNRUPTURED, FUSIFORM ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM MAX. DIAMETER WAS 6MM. LANDING ZONE ARTERY SIZE WAS 4MM DISTAL AND 4.75MM PROXIMAL. VESSEL TORTUOSITY WAS MODERATE. THE PIPELINE FLEX WAS IMPLANTED WITH GOOD PLACEMENT AND WALL APPOSITION. THE PATIENT WAS ADMINISTERED DUAL ANTIPLATELET TREATMENT. FOUR DAYS POST-PROCEDURE, THE PATIENT REPORTEDLY EXPERIENCED A MASSIVE INTRAPARENCHYMAL HEMORRHAGE. THE PATIENT PRESENTED IN THE ER WITH PRU OF 4. AT THE TIME OF THE PROCEDURE, THE PATIENT'S PRU WAS APPROXIMATELY 90. THE PATIENT HAS SINCE PASSED AWAY.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED ADDITIONAL EVENT INFORMATION: AFTER PRESENTING IN THE ER WITH INTRAPARENCHYMAL HEMORRHAGE (IPH), THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693921 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) PED-475-20 A143464

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death