BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3892060 · Received June 24, 2014

    Report

    Report Number
    2029214-2014-00356
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSHWIRE WAS RETURNED FOR EVALUATION BROKEN AT APPROXIMATELY 188CM FROM THE PROXIMAL END WITHOUT THE PIPELINE AND THE BROKEN SEGMENT (CAPTURE COIL AND DISTAL TIP COIL) AS THE PIPELINE WAS IMPLANTED IN THE PATIENT AND THE BROKEN SEGMENT REMAINS IN THE PATIENT. CROSS SECTIONAL ANALYSIS OF THE BREAK SURFACE INDICATED THAT THEY CAUSE OF FAILURE WAS DUE TO TORSIONAL OVERLOAD. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGE AND IRREGULARITIES DURING MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF TWO SACCULAR RIGHT PCA (POSTERIOR CEREBRAL ARTERY) ANEURYSMS. THE PATIENT WAS GIVEN ASPIRIN AND PLAVIX PRIOR TO THE PROCEDURE AND GIVEN HEPARIN INTRA-OPERATIVELY. ON (B)(6) 2014, THE PATIENT UNDERWENT COILING AND PIPELINE EMBOLIZATION TREATMENT. THE DISTAL ANEURYSM WAS COILED FIRST. COILS WERE ALSO PLACED IN THE PROXIMAL ANEURYSM AND A PIPELINE (3.25MM X 16MM) WAS DEPLOYED ACROSS THE NECK OF THE PROXIMAL ANEURYSM. UPON ADVANCING THE MARKSMAN CATHETER THROUGH THE PIPELINE IN ORDER TO RETRIEVE THE CAPTURE COIL, THE CAPTURE COIL SEPARATED FROM THE PUSHWIRE. AN ATTEMPT WAS MADE TO RECOVER THE BROKEN DISTAL TIP WITH AN AMPLATZ SNARE, BUT WITHOUT SUCCESS. THE BROKEN SEGMENT REMAINS WITHIN THE RIGHT PCA AND THERE WILL BE NO ATTEMPT TO RETRIEVE THE BROKEN SEGMENT. THE PATIENT WAS REPORTED TO BE IN STABLE AND GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369069 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77325-16 9868820

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention| S