BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4508811 · Received February 11, 2015

    Report

    Report Number
    2029214-2015-00113
    Event Type
    Injury
    Date Received
    February 11, 2015
    Report Date
    January 12, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS CREATED TO CAPTURE THE 2 POST PROCEDURAL COMPLICATIONS AND THE 3 RETREATMENTS POST PIPELINE PROCEDURE FROM THE ARTICLE: ZANATY ET AL. FLOW DIVERSION VERSUS CONVENTIONAL TREATMENT FOR CAROTID CAVERNOUS ANEURYSMS. STROKE. 2014; 45:2656-2661. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: ZANATY ET AL. FLOW DIVERSION VERSUS CONVENTIONAL TREATMENT FOR CAROTID CAVERNOUS ANEURYSMS. STROKE. 2014; 45:2656-2661. ONE HUNDRED FIFTY-SEVEN PATIENTS WITH NO DIFFERENCE IN MEAN AGE AND MEAN SEX HARBORING ANEURYSMS LOCATED IN THE CAVERNOUS SEGMENT OF THE ICA (INTERNAL CAROTID ARTERY) WERE TREATED WITH PIPELINES, COILS (STENT ASSISTED), AND CAROTID VESSEL DESTRUCTION. PROCEDURAL COMPLICATIONS, ANGIOGRAPHIC RESULTS, AND CLINICAL OUTCOMES WERE ANALYZED AND COMPARED. . THE PATIENTS TREATED WITH PIPELINE HAD A SIGNIFICANTLY LOWER PROPORTION OF SMALL SIZE ANEURYSMS (<10 MM) AND A SHORTER FOLLOW-UP DURATION. FIFTY NINE PATIENTS RECEIVED PIPELINE DEVICES AND 48 OF THOSE PATIENTS ACHIEVED COMPLETE OCCLUSION OF THE ANEURYSM. OUT OF THE 59 PATIENTS WHO RECEIVED PIPELINES, ONE PATIENT HAD AN ANEURYSM RUPTURE POST TREATMENT AND ONE PATIENT HAD A HEMORRHAGIC STROKE POST PROCEDURE. THREE PIPELINE PATIENTS REQUIRED RETREATMENT AFTER THE INITIAL PROCEDURE DUE TO EITHER RECANALIZATION, FAILURE OF OCCLUSION, OR WORSENING OF SYMPTOMS. THERE WERE NO PROCEDURE RELATED DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101543 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S