BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 6024618 · Received October 12, 2016

    Report

    Report Number
    2029214-2016-00892
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    August 23, 2016
    Report Date
    October 11, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE DEVICE WILL NOT BE RETURNED AS IT REMAINS IMPLANTED IN THE PATIENT. IN THIS EVENT, THERE WAS NO INDICATION OF ANY DEVICE ISSUES. PER THE ARTICLE AUTHORS, THE CAUSE OF IN-STENT THROMBOSIS AFTER PIPELINE IMPLANTATION IS LIKELY DUE TO THE PATIENT'S NON-COMPLIANCE TO DUAL ANTIPLATELETS. ZANATY, M. ET AL. SAME-DAY DISCHARGE AFTER TREATMENT WITH THE PIPELINE EMBOLIZATION DEVICE USING MONITORED ANESTHESIA CARE. WORLD NEUROSURG. (2016) 96:31-35. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.08.050.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM LITERATURE THAT A PATIENT EXPERIENCED IN-STENT THROMBOSIS AFTER PIPELINE IMPLANTATION. THE OBJECTIVE OF THIS ARTICLE WAS TO ASSESS THE SAFETY AND FEASIBILITY OF SAME-DAY DISCHARGE IN PATIENTS UNDERGOING PIPELINE IMPLANTATION UNDER MONITORED ANESTHESIA CARE. A TOTAL OF 130 PATIENTS WITH 143 CEREBRAL ANEURYSMS WERE IDENTIFIED. MEAN AGE OF THE PATIENTS WAS 60.7 YEARS; 36 OF THE PATIENTS WERE MEN. THERE WAS REPORTEDLY ONE PERI-PROCEDURAL INTRACRANIAL COMPLICATION. THE PATIENT UNDERWENT TREATMENT OF A LEFT P1 ANEURYSM AND WAS DISCHARGED HOME THE SAME DAY. THE PATIENT WAS REPORTEDLY NOT COMPLIANT WITH CLOPIDOGREL AND ASPIRIN PRIOR TO OR AFTER THE PROCEDURE. THE PATIENT SUBSEQUENTLY DEVELOPED RIGHT-SIDED WEAKNESS AND RIGHT HEMIANOPIA FROM IN-STENT THROMBOSIS AND RESULTANT POSTERIOR CEREBRAL ARTERY INFARCT. ONE-DAY POST-PROCEDURE, THE PATIENT UNDERWENT AN EMERGENCY MECHANICAL THROMBECTOMY, WHICH RESULTED IN COMPLETE NEUROLOGIC RECOVERY. THE PATIENT'S MRS WAS 1 AT THE TIME OF DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672128 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention