BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4659424 · Received April 3, 2015

    Report

    Report Number
    2029214-2015-00341
    Event Type
    Injury
    Date Received
    April 3, 2015
    Date of Event
    January 26, 2012
    Report Date
    March 6, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS CREATED TO CAPTURE THE COMPLICATIONS INVOLVING THE PIPELINE. THE INFORMATION WAS RECEIVED FROM THE ARTICLE: PISTOCCHI S, BLANC R, BARTOLINI B, ET AL. FLOW DIVERTERS AT AND BEYOND THE LEVEL OF THE CIRCLE OF WILLIS FOR THE TREATMENT OF INTRACRANIAL ANEURYSMS. STROKE 2012;43:1032-38. HTTP://STROKE.AHAJOURNALS.ORG/CONTENT/43/4/1032 THE DEVICE WILL NOT BE RETURNED AS IT WAS IMPLANTED IN THE PATIENT. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT REPORTED. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: PISTOCCHI S, BLANC R, BARTOLINI B, ET AL. FLOW DIVERTERS AT AND BEYOND THE LEVEL OF THE CIRCLE OF WILLIS FOR THE TREATMENT OF INTRACRANIAL ANEURYSMS. STROKE 2012;43:1032-38. MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM LITERATURE REVIEW STATING THAT ONE PATIENT WHO WAS TREATED WITH A PIPELINE EMBOLIZATION DEVICE (PED) EXPERIENCED PERMANENT NEUROLOGICAL COMPLICATION. IN THIS CASE, A LEFT LARGE (DIAMETER 19.6 MM) MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM THAT HAD ALREADY RECURRED TWICE WAS TREATED FOR THE THIRD TIME WITH TWO PEDS AND COILS. THE DAY AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH SUDDEN RIGHT HEMIPLEGIA AND APHASIA. AN ANGIOGRAM WAS IMMEDIATELY CARRIED OUT SHOWING COMPLETE PED THROMBOSIS. BALLOON ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE) WAS PERFORMED AND THE PARENT ARTERY FLOW WAS RESTORED. DESPITE THAT, THE PATIENT SUSTAINED A CEREBRAL INFARCT WITH SUBSEQUENT NEUROLOGICAL DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223924 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-77250-12

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R