BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3864226 · Received June 10, 2014

    Report

    Report Number
    2029214-2014-00329
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 12, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    ALMANDOZ JE, CRANDALL BM, SCHOLZ JM, FEASE JL, ANDERSON RE, KADKHODAYAN Y, ET AL. PRE-PROCEDURE P2Y12 REACTION UNITS VALUE PREDICTS PERIOPERATIVE THROMBOEMBOLIC AND HEMORRHAGIC COMPLICATIONS IN PATIENTS WITH CEREBRAL ANEURYSMS TREATED WITH THE PIPELINE EMBOLIZATION DEVICE. J NEUROINTERVENT SURG. 2013; 00:1-8. ON (B)(6) 2014, A LITERATURE ARTICLE WAS RECEIVED DESCRIBING A TOTAL OF 44 PATIENTS (8 MALE / 36 FEMALE) WITH A MEAN AGE OF 59.2 YEARS WHO UNDERWENT 48 PED (PIPELINE EMBOLIZATION DEVICE) SURGERIES. THREE PATIENT CASE STUDIES WERE PROVIDED OUT OF 44 PATIENTS. ALL THREE PATIENTS WERE GIVE ANTIPLATELET THERAPY. CASE #2: TREATMENT OF A LARGE FUSIFORM ANEURYSM MEASURING 21MM LOCATED IN THE CAVERNOUS SEGMENT OF THE RIGHT ICA (INTERNAL CAROTID ARTERY). THE PATIENT PRESENTED WITH DIPLOPIA AND RIGHT CRANIAL NERVE VI PALSY. THE PATIENT WAS CONSIDERED A CLOPIDOGREL HYPORESPONDER WITH A PRU (P2Y12 REACTION UNIT) VALUE OF 259 ON THE DAY BEFORE THE PROCEDURE AFTER 9 DAYS OF CLOPIDOGREL THERAPY. ADDITIONAL ANTIPLATELET THERAPY (PRASUGREL) WAS PROVIDED. PRE-PROCEDURE PRU VALUE WAS 8 ON THE DAY OF THE PROCEDURE. THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT AND HAD TWO PIPELINES DEPLOYED AND IMPLANTED. IMAGING REVEALED CONSTRUCT FAILURE WITH HERNIATION INTO THE ANEURYSM SAC. TWO ADDITIONAL PIPELINES WERE IMPLANTED. POST PROCEDURAL ANGIOGRAM REVEALED CONTRAST STASIS IN THE ANEURYSM AND PATENT CEREBRAL VASCULATURE. ON POSTOPERATIVE DAY 10, THE PRU VALUE WAS ZERO. ANTIPLATELET THERAPY WAS HELD FOR 3 DAYS AND THE DAILY DOSE WAS DECREASED THEREAFTER. IN THE EVENING OF POSTOPERATIVE DAY 13 THE PATIENT WAS FOUND TO BE LESS INTERACTIVE BY FAMILY MEMBERS, BUT DID NOT SEEK MEDICAL ATTENTION. ON POSTOPERATIVE DAY 14, THE PATIENT EXPERIENCED LEFT-SIDED HEMIPLEGIA. A NON-CONTRAST CT (COMPUTED TOMOGRAPHY) SCAN REVEALED A LARGE RIGHT BASAL GANGLIA INTRACEREBRAL HEMORRHAGE. THE PATIENT WAS DISCHARGED WITH A PERMANENT DISABILITY OF LEFT-SIDED HEMIPLEGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337915 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention| S