BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4233416 · Received November 6, 2014

    Report

    Report Number
    2029214-2014-00624
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DISTAL BROKEN PUSHWIRE SEGMENT (DISTAL TIP COIL / CAPTURE COIL) WAS RETURNED FOR EVALUATION WITHOUT THE PROXIMAL BROKEN SEGMENT WAS IT WAS DISCARDED. IT WAS BROKEN AT APPROXIMATELY 5CM FROM THE TIP COIL. CROSS SECTIONAL ANALYSIS OF THE BREAK SURFACE INDICATED THAT THE FAILURE MODE WAS CONSISTENT WITH TORSIONAL OVERLOAD. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. (B)(6). (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING FOUR PIPELINES. DURING THE PROCEDURE, IT WAS REPORTED TWO OF THE PIPELINES HAD THEIR DISTAL TIP COIL / CAPTURE COIL SEPARATED FROM THE PUSHWIRE. THE BROKEN SEGMENTS WERE REMOVED FROM THE PATIENT WITH A SNARE AND ALLIGATOR RETRIEVAL DEVICE. ALL THE PIPELINES WERE SUCCESSFULLY IMPLANTED IN THE PATIENT. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2014-00623.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713991 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT COVIDIEN FA-77425-14 9582599

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention