BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3770594 · Received April 24, 2014

    Report

    Report Number
    2029214-2014-00231
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 28, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014 STATING THAT THE SEVERE SERIOUS ADVERSE EVENT THAT OCCURRED ON (B)(6) 2014 WITH SYMPTOMS NOTED AS LEFT-SIDED HEMIPARESIS, DECREASED RESPONSIVENESS, LEFT-SIDED FACIAL DROOP, LETHARGY, AND A DIAGNOSIS OF INTRAPARENCHYMAL HEMATOMA CENTERED WITHIN THE RIGHT SUPERIOR TEMPORAL/PARIETAL LOBES (IMAGING REVEALED INSULAR PARENCHYMAL HEMATOMA) WAS ADJUDICATED FROM DEVICE RELATED TO PROCEDURE RELATED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(4). TREATMENT OF A LARGE UNRUPTURED RESIDUAL ANEURYSM MEASURING 20MM LOCATED IN THE RIGHT ICA (INTERNAL CAROTID ARTERY) THAT WAS PREVIOUSLY TREATED WITH COILS IN THE SETTING OF AN SAH (SUBARACHNOID HEMORRHAGE) IN 2013. THE PATIENT WAS GIVEN ASPIRIN AND PLAVIX PRIOR TO THE PROCEDURE AND HEPARIN WAS ADMINISTERED INTRA-OPERATIVELY. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE (3.25MM X 18MM) EMBOLIZATION TREATMENT AND EXPERIENCED SEVERE, SERIOUS ADVERSE EVENT WITH SYMPTOMS NOTED AS LEFT-SIDED HEMIPARESIS, LETHARGY, DECREASED RESPONSIVENESS, AND LEFT SIDED FACIAL DROOP WITH A DIAGNOSIS OF INTRAPARENCHYMAL HEMATOMA CENTERED WITHIN THE RIGHT SUPERIOR TEMPORAL/PARIETAL LOBES AFTER THE PROCEDURE. IMAGING REVEALED AN ACUTE RIGHT INSULAR PARENCHYMAL HEMATOMA MEASURING 5.2CM ASSOCIATED WITH MASS EFFECT AND LEFTWARD MIDLINE SHIFT. STASIS WAS ALSO NOTED IN THE RESIDUAL ANEURYSM AFTER THE TREATMENT. THE PATIENT RECEIVED 2 UNITS OF PLATELETS THE NIGHT OF (B)(6) 2014. ON (B)(6) 2014, IMAGING REVEALED A STABLE PARENCHYMAL HEMORRHAGE CENTERED AT THE POSTERIOR MARGIN OF THE RIGHT SYLVIAN FISSURE WITH STABLE INTRAVENTRICULAR EXTENSION AND STABLE MASS EFFECT AND MIDLINE SHIFT. NO NEW FINDINGS. MEDICATION AND CONTINUED HOSPITALIZATION WERE REQUIRED TO TREAT THE SERIOUS ADVERSE THAT WAS REPORTED TO BE DEVICE RELATED AND IS ONGOING. THE PATIENT WAS IN THE CCU (CRITICAL CARE UNIT) PRIOR TO BEING DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249682 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77325-18 9813897

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention| S