BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3981252 · Received August 5, 2014

    Report

    Report Number
    2029214-2014-00463
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 11, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM AN ARTICLE: NAVARRO R, YOON J, DIXON T, ET AL. RETROGRADE TRANS-ANTERIOR COMMUNICATING ARTERY RESCUE OF UNOPENED PIPELINE EMBOLIZATION DEVICE WITH BALLOON DILATION: COMPLICATION MANAGEMENT. J NEUROINTERVENT SURG. 2014;00:1-5. TREATMENT OF AN ANEURYSM MEASURING 10MM X 4.7MM LOCATED IN THE CAVERNOUS SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). THE PATIENT PRESENTED WITH INCREASED LEFT RETRO-ORBITAL PAIN. THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON AN UNSPECIFIED DATE. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY WAS GIVEN. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, IT WAS REPORTED THAT DIFFICULTY WAS EXPERIENCED DURING THE INITIAL ACCESS AND PIPELINE (5MM X 16MM) DEPLOYMENT. ONCE ACCESS WAS ACHIEVED, THE PIPELINE WAS UNSHEATHED IN THE ICA TERMINUS. THERE WAS DIFFICULTY IN ATTEMPTING TO OPEN THE DISTAL PART OF THE PIPELINE AND IT REQUIRED MANIPULATION AND ROTATION OF THE PUSHWIRE (LESS THAN 10 TIMES CLOCKWISE). THE PIPELINE WAS DEPLOYED WITH SATISFACTORY COVERAGE OF THE ANEURYSM NECK UNTIL THE PROXIMAL HORIZONTAL PORTION OF THE CAROTID SIPHON WAS REACHED WHERE THE PIPELINE FAILED TO OPEN DESPITE MANIPULATION OF THE PUSHWIRE AND CATHETER. THE PHYSICIAN ATTEMPTED TO ACCESS THROUGH THE CONSTRICTED PROXIMAL END OF THE PIPELINE WITH A PROWLER PLUS MICROCATHETER, BUT WITHOUT SUCCESS. A HYPERFORM BALLOON (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE, U.S.) WAS ALSO USED, BUT WITHOUT SUCCESS. AN ATTEMPT WAS MADE TO RETRIEVE THE DEVICE WITH AN ALLIGATOR RETRIEVAL DEVICE, BUT THIS ALSO PROVED TO BE UNSUCCESSFUL. AFTER MULTIPLE FAILED ATTEMPTS TO OPEN AND REMOVE THE PIPELINE, A CCF (CAROTID CAVERNOUS FISTULA) WAS NOTICED AND A DECISION WAS MADE TO ATTEMPT TO OPEN THE PIPELINE THROUGH THE CONTRALATERAL ACA (ANTERIOR CEREBRAL ARTERY). ACCESS TO THE UN-OPENED PORTION OF THE PIPELINE WAS GAINED FROM THE CONTRALATERAL SIDE AND BALLOON ANGIOPLASTY WAS PERFORMED. THE PIPELINE ACHIEVED FULL WALL APPOSITION WITH THE THIRD INFLATION OF THE BALLOON. SOME ATTEMPTS WERE MADE TO LOCATE AND TREAT THE FISTULA; HOWEVER, IT PROVED TO BE TOO DIFFICULT AND THE PROCEDURE WAS CONCLUDED. THE PATIENT HAD NO NEUROLOGICAL DEFICITS AND THERE WAS NO CLINICAL EVIDENCE OF THE CCF. AT 24 HOURS POST PROCEDURE, ANGIOGRAM REVEALED THE PIPELINE WAS IN STABLE POSITION AND NO RADIOGRAPHIC CHANGES IN THE FISTULA. SEVEN MONTHS POST PROCEDURE, ANGIOGRAM SHOWED COMPLETE OBLITERATION OF THE ANEURYSM AND FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458545 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-16 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention| S