BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3581846 · Received January 17, 2014

    Report

    Report Number
    2029214-2014-00018
    Event Type
    Injury
    Date Received
    January 17, 2014
    Date of Event
    November 25, 2013
    Report Date
    December 19, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ADDITIONAL INFORMATION ON (B)(4) 2014: (PROCEDURE AND EVENT DATES WERE CHANGED). ON (B)(6) 2013, THE PATIENT WAS TREATED WITH THE PLACEMENT OF 3 PIPELINE EMBOLIZATION DEVICES. THE RETROBULBAR PAIN AND VISION PROBLEMS SUBSIDED AFTER THE PROCEDURE. ON THE SAME DAY, THE PATIENT EXPERIENCED A LOW GRADE OCULOMOTOR PALSY ON THE RIGHT SIDE ON RETURN TO THE WARD POST PROCEDURE. NO OTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT AND NO TREATMENT WAS NOTED. THE SERIOUSNESS AND SEVERITY OF THE EVENT WAS UNKNOWN. ON (B)(6) 2013, SUBJECT EXPERIENCED A MILD A SERIOUS ADVERSE EVENT OF A CONTRALATERAL INTRACRANIAL CEREBELLAR HEMORRHAGE WITH SURROUNDING EDEMA WITH A SLIGHT PELLETING OF THE 4TH VENTRICLE WITHOUT SIGNS OF CEREBROSPINAL FLUID ACCUMULATION. THE FRESH BLEEDING WAS NOTED AS BEING WITH A DIAMETER OR 1.7 X 2.5 CM. NO TREATMENT WAS NEEDED. IT IS NOTED THAT THE CEREBELLAR HEMORRHAGE WAS MOST LIKELY DUE TO THE IMPLANT OF FLOW DIVERTER AS PREVIOUSLY STATED. THE EVENT IS NOW NOTED AS RELATED TO THE PROCEDURE. ON (B)(6) 2013, THE EVENT RESOLVED. THE OTHER DEVICES USED IN THE EVENT ARE AS FOLLOWS: MODEL: FA-71450-25, LOT: 9545813, DOM: 08 FEB 2012, EXP: 07 FEB 2015. MODEL: FA-71500-25, LOT: 9533036, DOM: 09 JAN 2012, EXP: 08 JAN 2015. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(4). TREATMENT OF AN UNRUPTURED FUSIFORM BIFURCATION ANEURYSM LOCATED IN THE RIGHT ICA (INTERNAL CAROTID ARTERY ANEURYSM). THE PATIENT PRESENTED WITH NEUROLOGICAL SYMPTOMS OF DIZZINESS, LOSS OF BALANCE / COORDINATION, AND HEADACHE. ON (B)(6) 2013, THE PATIENT WAS TREATED WITH THE PLACEMENT OF 3 PIPELINE EMBOLIZATION DEVICES. THE SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL PRIOR TO THE PROCEDURE AND WAS GIVEN HEPARIN INTRA-OPERATIVELY. POST PROCEDURE, THE PATIENT EXPERIENCED A MILD, SERIOUS ADVERSE EVENT OF INTRACRANIAL CEREBELLAR HEMORRHAGE. NO TREATMENT WAS NEEDED AND THE EVENT RESOLVED THE SAME DAY AS THE PROCEDURE. IT IS NOTED THAT THE CEREBELLAR HEMORRHAGE MOST LIKELY IS DUE TO IMPLANT OF FLOW DIVERTER. THE EVENT IS NOTED AS UNKNOWN RELATIONSHIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45632 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77450-20 9552597

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability