BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3820170 · Received May 20, 2014

    Report

    Report Number
    2029214-2014-00292
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS LOST AFTER THE PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A SMALL AMORPHOUS ANEURYSM MEASURING 7.8MM X 7MM. THE PATIENT HAD A HEMORRHAGIC STROKE ONE WEEK PRIOR TO THE PIPELINE PROCEDURE AND WAS WEAK IN THE LEFT ARM. THE PATIENT WAS GIVEN DUAL-ANTIPLATELET THERAPY. ON 05 MAY 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE FIRST PIPELINE (5MM X 18MM) DID NOT OPEN PROXIMALLY AND HAD TO BE REMOVED WITH A SNARE. THE SECOND PIPELINE (5MM X 20MM) ALSO DID NOT OPEN AND WAS REMOVED BY TRAPPING THE PIPELINE BETWEEN THE CAPTURE COIL AND CATHETER. THE THIRD DEVICE (5MM X 20MM) WAS IMPLANTED AND DID NOT OPEN AT FIRST, BUT EVENTUALLY OPENED WITH THE HELP OF A SEPTORIA BALLOON THAT WAS ADVANCED THROUGH THE P-COMM (POSTERIOR COMMUNICATING ARTERY) IN ORDER TO ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE, U.S.) THE PIPELINE OPEN. THE PATIENT WAS VERY SLOW TO WAKE UP AND SHE ALSO EXPERIENCED MILD APHASIA POST PROCEDURE THAT RESOLVED OVER A FEW DAYS. THE PHYSICIAN BELIEVED THESE EVENTS MAY HAVE BEEN DUE TO THE PREVIOUS STROKE COMBINED WITH A LONG TIME UNDER ANESTHESIA. THE PATIENT WAS ON ASPIRIN AND PLAVIX AND WAS DOING FINE. SAME EVENT AS MDR# 2029214-2014-00291 AND 2029214-2014-00293.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299160 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-20 9771464

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR