BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4153160 · Received October 8, 2014

    Report

    Report Number
    2029214-2014-00560
    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 Location
    SP
    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. THE GENDER WAS NOT SPECIFIED IN THE ARTICLE, BUT THE RADIOL BUTTON FOR FEMALE IS MARKED WITH NO WAY TO REMOVE IT. PLEAS NOTE THAT THE SEX FOR THIS REPORT IS ACTUALLY UNKNOWN AND NOT FEMALE. (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# 10: A PATIENT IN HIS/HER LATE 60¿S WITH A SMALL UNRUPTURED FUSIFORM ANEURYSM MEASURING 8MM LOCATED IN THE LEFT CAROTID T WAS TREATED WITH ONE PED (3.75MM X 18MM) ON AN UNSPECIFIED DATE. POST PROCEDURE, IT WAS REPORTED THE PATIENT HAD MINOR APHASIA AND A MINOR SYMPTOMATIC EMBOLIC STROKE. THE APHASIA RESOLVED SPONTANEOUSLY 24 HOURS POST PROCEDURE AND THE MINOR SYMPTOMATIC EMBOLIC STROKE RESOLVED A DAY AFTER THAT. AT SIX MONTHS FOLLOW-UP, ANGIOGRAPHY SHOWED A RESIDUAL ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632212 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT IRVINE FA-77375-18 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability