BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3942543 · Received July 17, 2014

    Report

    Report Number
    2029214-2014-00410
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, IT WAS REPORTED THE FIBROUS SEGMENT IN THE ICA (INTERNAL CAROTID ARTERY) WAS CALCIUM AND IT WAS NOT TREATED. RECEIVED CLARIFICATION OF EVENT DESCRIPTION ON (B)(6) 2014 STATING THAT THE LAST PIPELINE IMPLANTED (ON (B)(6) 2014) IN THE PATIENT REQUIRED BALLOON ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE, U.S.) TO ACHIEVE FULL WALL APPOSITION. MDR# 2029214-2014-00430 WAS CREATED FOR THIS PIPELINE AND IS THE SAME EVENT AS THIS ONE (MDR# 2029214-2014-00410). THE FOLLOWING MDRS ARE NOW LINKED TOGETHER: 2029214-2014-00430, 2029214-2014-00410, 2029214-2014-00413. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A GIANT ANEURYSM MEASURING 28MM X 8MM LOCATED IN THE CAVERNOUS SEGMENT OF THE ICA (INTERNAL CAROTID ARTERY). THE PATIENT WAS GIVEN DUAL ANTIPLATELET THERAPY (ASPIRIN AND PLAVIX). ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE PIPELINE (4MM X 25MM) COULD NOT BE RELEASED FROM THE CAPTURE COIL. THE PIPELINE WAS REMOVED FROM THE PATIENT AND A CLOT WAS NOTED IN THE ICA AFTER REMOVAL OF THE DEVICE. INTRA-ARTERIAL REOPRO WAS ADMINISTERED TO THE PATIENT AND THE PROCEDURE WAS ABORTED WITH NO RESIDUAL COMPLICATIONS. IT WAS LATER DISCOVERED THAT THE CLOT OBSERVED IN THE ICA WAS ACTUALLY A FIBROUS SEGMENT OF THE ICA AND WAS NOT TREATED. ON (B)(6) 2014, THE PATIENT UNDERWENT RETREATMENT. DURING THIS PROCEDURE, IT WAS REPORTED THE PIPELINE (5MM X 18MM) WAS NOT OPENING CORRECTLY AND IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. POST PROCEDURAL ANGIOGRAM SHOWED SLOW FLOW INTO THE ANEURYSM. ON (B)(6) 2014, THE PATIENT WAS DISCHARGED WITHOUT ANY INJURIES. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2014-00413.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418028 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71400-25 9899517

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR