BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3940894 · Received July 17, 2014

    Report

    Report Number
    2029214-2014-00408
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 17, 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 DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: FA-77475-20 / LOT: NA DOM: NA EXP: NA. MODEL: FA-77500-20 / LOT: NA DOM: NA EXP: NA. MODEL: FA-77500-18 / LOT: NA DOM: NA EXP: NA (QTY. 2). (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: MONTEITH SJ, M.D., TSIMPAS A, M.D., M.SC., DUMONT AS, MD., ET AL. ENDOVASCULAR TREATMENT OF FUSIFORM CEREBRAL ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE. J NEUROSURG 120. 2014:945-954. A TOTAL OF 146 PATIENT WERE TREATED WITH PIPELINE EMBOLIZATION DEVICE (PED). 24 OF THE 144 WERE IDENTIFIED AS HAVING FUSIFORM ANEURYSMS (9 MEN AND 15 WOMEN) WITH A MEAN AGE OF 59 YEARS. ALL THE PATIENTS WERE GIVEN ANTI-PLATELET THERAPY. 23 OF THE 24 HAD NO PROCEDURAL COMPLICATIONS. ONE HAD A GROIN PSEUDOANEURYSM THAT WAS MANAGED CONSERVATIVELY. 4 OF THE 24 HAD MAJOR COMPLICATIONS RELATED TO THE ANEURYSM TREATMENT AND THERE WAS ONE DEATH. CASE 1: TREATMENT OF A GIANT FUSIFORM ANEURYSM MEASURING 21MM X 29MM X19MM LOCATED IN THE CAVERNOUS SEGMENT OF THE ICA (INTERNAL CAROTID ARTERY). THE PATIENT PRESENTED WITH DIPLOPIA AND UNDERWENT PIPELINE EMBOLIZATION TREATMENT WITHOUT ISSUES INVOLVING FOUR PIPELINES (4.75MM X 20MM / 5MM X 20MM / 5MM X 18MM, QTY. 2) WITHOUT ISSUES. 1 WEEK POST PROCEDURE, THE PATIENT SUFFERED A SIGNIFICANT FRONTAL INTRACEREBRAL HEMORRHAGE AND WAS TRANSFERRED TO A LONG-TERM CARE FACILITY WITH HEMIPLEGIA AND A PERCUTANEOUS ENDOSCOPIC G-TUBE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420070 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77475-20 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Disability