BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3892293 · Received June 24, 2014

    Report

    Report Number
    2029214-2014-00345
    Event Type
    Death
    Date Received
    June 24, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 30, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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

    TREATMENT OF A GIANT ANEURYSM LOCATED IN THE CAVERNOUS SEGMENT OF THE ICA (INTERNAL CAROTID ARTERY) THAT WAS PREVIOUSLY STENTED (NEUROFORM) AND COILED IN 2003, BUT HAS RECANALIZED. THE PATIENT PRESENTED WITH WORSENING HEADACHES AND 3RD NERVE PALSY. THE PATIENT WAS GIVEN PLAVIX AND ASPIRIN. ON (B)(6) 2014, THE PATIENT UNDERWENT RETREATMENT WITH A PIPELINE (4.75MM X 25MM) AND THE ANEURYSM MEASURED 12.5MM X 20MM X 20MM BASED ON ANGIOGRAPHY AND 31.5MM X 27MM X 25MM BASED ON MRI (PARTIALLY THROMBOSED). THE ACCESS WAS EXTREMELY DIFFICULT. DURING THE PROCEDURE, IT WAS REPORTED THAT ATTEMPTS TO CANNULATE THE INDWELLING STENT PROVED TO BE UNSUCCESSFUL AND ACCESS FROM THE CONTRALATERAL SIDE ACROSS THE A-COMM (ANTERIOR COMMUNICATING) ARTERY WAS ALSO UNSUCCESSFUL. THE STENT WAS ACCESSED THROUGH ITS SIDE AND ANGIOPLASTIED OPEN IN ORDER TO PLACE THE PIPELINE. POST PROCEDURAL ANGIOGRAPHY REVEALED GOOD PLACEMENT OF THE PIPELINE. THE PRU LEVELS WERE 80 ON (B)(6) 2014 AND 147 ON (B)(6) 2014. ON (B)(6) 2014 AT 8AM, THE PATIENT PRESENTED WITH ACUTE ONSET OF HEADACHE AND MS CHANGE AND A CT (COMPUTED TOMOGRAPHY) SCAN REVEALED A RIGHT INTRAPARENCHYMAL HEMORRHAGE. SURGERY WAS PERFORMED TO DECOMPRESS THE SWELLING, BUT THE PATIENT SUBSEQUENTLY SUFFERED A HEMORRHAGE ON THE CONTRALATERAL SIDE AS WELL. THE PRU LEVELS WERE 91 AT 9AM ON (B)(6) 2014 / 153 AT 10AM ON (B)(6) 2014 / 207 AT 11AM ON (B)(6) 2014, AND 187 ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369347 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71475-25 9782158

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death