BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4153198 · Received October 8, 2014

    Report

    Report Number
    2029214-2014-00562
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    IRVINE
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 MARTI-NEZ-GALDAMEZ M, ROMANCE A, VEGA P, ET AL. PIPELINE ENDOVASCULAR DEVICE FOR THE TREATMENT OF INTRACRANIAL ANEURYSMS AT THE LEVEL OF THE CIRCLE OF WILLIS AND BEYOND: MULTICENTER EXPERIENCE. J NEUROINTERVENT SURG. DOI: 10.1136/ NEURINTSURG-2014-011355. A TOTAL OF 25 PATIENTS (15 WOMEN AND 10 MEN) WITH ANTERIOR CIRCULATION ANEURYSMS WERE TREATED WITH A PIPELINE EMBOLIZATION DEVICE (PED) AT THE LEVEL OF THE CIRCLE OF WILLIS AND BEYOND. ALL PATIENTS WERE PRE-MEDICATED WITH DOUBLE ANTI-PLATELET THERAPY (ASPIRIN AND CLOPIDOGREL / ONE PATIENT RECEIVED TICAGRELOR). THE PEDS WERE DEPLOYED THROUGH A MARKSMAN MICROCATHETER USING A TRI-AXIAL GUIDE CATHETER SYSTEM IN ALL CASES. ALL DEVICES WERE PLACED PROPERLY, WITHOUT TECHNICAL DIFFICULTIES. THERE WERE NO ANEURYSM RUPTURES, PARENCHYMAL HEMORRHAGES, OR DEVICE MIGRATIONS DURING THE FOLLOW UP. CASE# 11: A PATIENT IN HIS/HER LATE 50¿S WITH A GIANT UNRUPTURED SACCULAR ANEURYSM MEASURING 36MM LOCATED IN THE RIGHT A1-A2 PRESENTED WITH SEIZURES WAS TREATED WITH ONE PED (3MM X 14MM) ON AN UNSPECIFIED DATE. POST PROCEDURE, THE PATIENT WAS REPORTED TO HAVE DISORDERLY BEHAVIOR, DISORIENTATION IN TIME AND SPACE, AND WITH IMPAIRED RECENT MEMORY AND DISORGANIZED AND INCOHERENT SPEECH, SECONDARY TO DISTAL MULTI-EMBOLIC INFARCTS IN A GIANT PARTIALLY THROMBOSED ANEURYSM LOCATED IN THE RIGHT A1-A2 SEGMENT. THIS WAS TREATED WITH A PED AND COILS THROUGH THE CONTRALATERAL A1. THE DISTRIBUTION OF INFARCTS WERE MOSTLY IN THE ANTERIOR CEREBRAL ARTERY DISTAL TERRITORY, WHICH CAN BE EXPLAINED AS IT WAS A PARTIALLY THROMBOSED GIANT ANEURYSM. A RIGHT TEMPORAL LOBE SMALL INFARCT ALSO OCCURRED THAT MAY HAVE BEEN RELATED TO THE INTERNAL CAROTID ARTERY NAVIGATION OR TO ANY OTHER INTRA-PROCEDURAL MANEUVER NOT RELATED TO THE ANEURYSM LOCATION. THE DISTAL MULTI-EMBOLIC STROKE WAS ONGOING. AT 6 MONTHS FOLLOW-UP, ANGIOGRAPHY SHOWED OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632326 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT IRVINE FA-77300-14 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability