BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4101422 · Received August 28, 2014

    Report

    Report Number
    2029214-2014-00502
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVAL AS IT WAS IMPLANTED IN THE PT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    TREATMENT OF AN IRREGULAR WIDE NECK ANEURYSM MEASURING 6MM X 4MM LOCATED IN THE SUPRACLINOID SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). ON (B)(6) 2014, THE PT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. THE PHYSICIAN BELIEVED THE PT MAY HAVE BEEN NON-RESPONDENT TO PLAVIX; THEREFORE, THE PT WAS IMMEDIATELY CONVERTED TO EFFIENT. THE PLAVIX WAS DISCONTINUED. THE PRU (P2Y 12 REACTION UNITS) LEVELS FOR THE PROCEDURE AND AFTER THE PROCEDURE WERE UNK AS THE COUNT DOES NOT PERFORM PRU TESTING. DURING THE PROCEDURE, IT WAS REPORTED THE FIRST PIPELINE (5MM X 20MM) COULD NOT BE RELEASED FROM THE CAPTURE COIL AND THE PIPELINE WAS REMOVED FROM THE PT WITHOUT ISSUES. ANOTHER PIPELINE (5MM X 20MM) WAS IMPLANTED SUCCESSFULLY; HOWEVER, THE PT DEVELOPED A CLOT INSIDE THE 2ND PIPELINE POST PROCEDURE AND WAS BROUGHT BACK INTO THE LAB FOR MECHANICAL THROMBECTOMY. DURING THE MEDICAL THROMBECTOMY, INTRA-ARTERIAL TPA (TISSUE PLASMINOGEN ACTIVATOR) AND REOPRO WERE ADMINISTERED TO LYSE THE CLOT. THE REMAINING CLOT WAS REMOVED BY DIRECT ASPIRATION WITH A 5 MAX AND 3 MAX CATHETER. THE CLOT WAS A FRESH THROMBUS. AS OF (B)(6) 2014, THE PT WAS STILL IN-HOUSE AND WAS REPORTED TO BE IMPROVING AND WILL BE ATTENDING REHABILITATION SOON. THE PT'S RIGHT SIDED MOBILITY HAD IMPROVED IN 85% WITH NO SPEECH IMPEDIMENT. SAME EVENT AS MDR # 2029214-2014-00501.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523743 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION, PRODUCT CODE: OUT OUT EV3 NEUROVASCULAR FA-77500-20 9829447

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention