BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX

    MDR report key: 6101200 · Received November 14, 2016

    Report

    Report Number
    2029214-2016-01011
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 17, 2016
    Manufacturer
    MEDTRONIC COVIDIEN
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. WE ARE UNABLE TO DEFINITIVELY DETERMINE THE CAUSE OF REPORTED EXPERIENCE. BASED ON THE REPORTED EVENT DESCRIPTIONS, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. IT IS LIKELY THAT THE PATIENT ANATOMY AND BRAID SIZING MAY HAVE CONTRIBUTED TO THE REPORTED ISSUES. FURTHERMORE, THE PIPELINE FLEX IFU INDICATES: DO NOT USE THE PIPELINE FLEX EMBOLIZATION DEVICE IN VESSEL DIAMETERS THAT ARE LARGER THAN THE LABELED DIAMETER. SELECT AN APPROPRIATELY SIZED PIPELINE FLEX EMBOLIZATION DEVICE SUCH THAT ITS FULLY EXPANDED DIAMETER IS EQUIVALENT TO THAT OF THE LARGEST TARGET VESSEL. AN INCORRECTLY SIZED PIPELINE FLEX EMBOLIZATION DEVICE MAY RESULT IN INADEQUATE DEVICE PLACEMENT, INCOMPLETE OPENING, OR MIGRATION. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGE AND IRREGULARITIES DURING MANUFACTURE. MDRS RELATED TO THIS REPORT: 2029214-2016-01011 2029214-2016-01012.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING TREATMENT OF AN ANEURYSM LOCATED IN THE LEFT POSTERIOR COMMUNICATING ARTERY, THIS DEVICE (PED-425-35) LANDED AT THE DESIRED LOCATION. HOWEVER DURING PLANNED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) THE DEVICE FORESHORTENED CAUSING THE NECK TO NOT BE FULLY COVERED. IN ORDER TO COVER THE NECK COMPLETELY, A SECOND PIPELINE (PED-475-35) WAS PLACED. IT WAS REPORTED THAT THE PHYSICIAN PLANNED TO PLACE TWO PIPELINE DEVICES. HOWEVER, UPON PLACING THE SECOND PIPELINE, THE SAME MICROCATHETER WAS USED AND THE PHYSICIAN WAS UNABLE TO RESHEATH, AND THE INITIAL PIPELINE AND THE SECOND PIPELINE WERE APART. THE PHYSICIAN MADE SURE THE PUSHER AND CATHETER WERE ABLE TO PASS THROUGH THE PIPELINE IMPLANTED, AND TRIED TO ADVANCE THE GUIDEWIRE. HOWEVER, THE PHYSICIAN HAD DIFFICULTY REMOVING THE PUSHWIRE OF THE PIPELINE. THE PHYSICIAN THEN DECIDED TO CUT THE MICROCATHETER, A FEW TENTHS OF A CM FROM THE PROXIMAL END, EXPOSED THE PUSHER AND ATTEMPTED REMOVING FROM THE PATIENT BUT WAS UNABLE TO DO SO. THE PHYSICIAN EVENTUALLY REMOVED THE PUSHER IN TANDEM WITH THE MICROCATHETER. THE SECOND PIPELINE WAS NOT IMPLANTED IN THE INTENDED LOCATION AND THEREFORE A THIRD PIPELINE WAS THEN IMPLANTED BETWEEN THE FIRST TWO PIPELINES. THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED. THE ANEURYSM MAX DIAMETER WAS ESTIMATED TO BE 10 MM. THE ANEURYSM NECK IS UNKNOWN. THE PROXIMAL LANDING ZONE WAS 4.8 MM AND THE DISTAL LANDING ZONE WAS 4.1 MM. THE ANEURYSM WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY APPROXIMATELY 50 MM PROXIMAL OF THE PCOM BRANCH. THE PATIENT TORTUOSITY WAS MEDIUM LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750715 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MEDTRONIC COVIDIEN PED-425-35 A250469

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention