BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4101434 · Received August 28, 2014

    Report

    Report Number
    2029214-2014-00503
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 1, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE WAS RETURNED FOR EVAL WITHOUT THE PUSHWIRE AND THE CATHETER. THE PUSHWIRE WAS DISCARDED. THE EVAL COULD NOT DETERMINE THE CAUSE OF THE EVENT AS THE PIPELINE WAS FOUND FULLY OPENED; HOWEVER, THE BRAID WAS FOUND DAMAGED AND MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN UNRUPTURED BI-LOBED RIGHT SUPERIOR HYPOPHYSEAL ARTERY ANEURYSM MEASURING 6MM. ON (B)(6) 2014, THE PT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING TWO PIPELINES. THE PT WAS GIVEN DUAL ANTIPLATELET THERAPY (ASPIRIN AND PLAVIX) AND HEPARIN ACCORDING TO PROTOCOL. DURING THE PROCEDURE, IT WAS REPORTED THE FIRST PIPELINE (4MM X 16MM) WAS NOT OPENING PROPERLY UNDER FLUOROSCOPY DESPITE ADVANCED DEPLOYMENT TECHNIQUES. THE PIPELINE WAS REMOVED FROM THE PT BY TRAPPING THE PIPELINE BRAID BETWEEN THE CAPTURE COIL AND THE CATHETER. ANOTHER PIPELINE (4MM X 16MM) WAS IMPLANTED IN THE PT WITHOUT ISSUES. ON (B)(6) 2013, THE PT SUFFERED AN INTRACRANIAL HEMORRHAGE IN THE RIGHT BASAL GANGLIA, TEMPORAL, AND FRONTAL LOBES AND THE PT WAS REPORTED TO BE IN THE HOSPITAL. THE CAUSE OF THE HEMORRHAGE WAS UNK, BUT IT WAS LIKELY NOT AN ANEURYSM RUPTURE. IT WAS NOTICED BY THE PHYSICIAN THAT A HEMATOMA EVAL WAS PERFORMED. ON (B)(6) 2014, THE PT WAS REPORTED TO BE POOR CONDITION. THE PT WAS ALERT AND FOLLOWED SIMPLE COMMANDS WITH A DYSCONJUGATE GAZE AND GAZE PREFERENCE TO THE LEFT. THE PT HAD RIGHT SIDE SPONTANEOUS MOVEMENT AGAINST GRAVITY WITH EXTENDS ON LUE (LEFT UPPER EXTREMITIES) AND TRIPLE FLEX ON LLE (LOWER LEFT EXTREMITIES). SAME EVENT AS MDR # 2029214-2014-00504.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523905 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION, PRODUCT CODE: OUT OUT EV3 NEUROVASCULAR FA-77400-16 9929352

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention