BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 11016902 · Received December 16, 2020

    Report

    Report Number
    2029214-2020-01312
    Event Type
    Death
    Date Received
    December 16, 2020
    Date of Event
    September 26, 2019
    Report Date
    December 15, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CHERIAN, J., SRINIVASAN, V., FROEHLER, M. T., GROSSBERG, J. A., CAWLEY, C. M., HANEL, R. A., PURI, A., DUMONT, T., DUCRUET, A. F., ALBUQUERQUE, F., ARTHUR, A., CHEEMA, A., SPIOTTA, A., ANADANI, M., LOPES, D., SAIED, A., KIM, L., KELLY, C. M., CHEN, P. R., MOCCO, J. (2020). FLOW DIVERSION FOR TREATMENT OF INTRACRANIAL ANEURYSMS IN PEDIATRIC PATIENTS: MULTICENTER CASE SERIES. NEUROSURGERY, 87(1), 53¿62. DOI:10.1093/NEUROS/NYZ380 MEDTRONIC RECEIVED A LITERATURE ARTICLE AIMING TO REPORT TECHNICAL, ANGIOGRAPHIC, AND CLINICAL OUTCOMES IN PATIENTS AGED 21 OR BELOW UNDERGOING FLOW-DIVERSION TREATMENT FOR INTRACRANIAL ANEURYSMS. THE ARTICLE INCLUDED 39 PATIENTS UNDERGOING 46 TREATMENT SESSIONS WITH PIPELINE EMBOLIZATION DEVICE PLACEMENT BETWEEN 2012 AND 2018. A TOTAL OF 50 INTRACRANIAL ANEURYSMS WERE TREATED. THE STUDY INCLUDED A MAJORITY MALE PATIENTS. NONSACCULAR MORPHOLOGY WAS SEEN IN HALF OF IDENTIFIED ANEURYSMS. SIX ANEURYSMS WERE GIANT, AND FIVE PATIENTS WERE TREATED ACUTELY AFTER RUPTURED PRESENTATION. COMPLETE ANEURYSM OCCLUSION WAS SEEN IN 74% OF TREATED ANEURYSMS. IN THE FIRST CASE RELATED DEATH A (B)(6) YR-OLD BOY PRESENTED WITH SEVERE TRAUMATIC BRAIN INJURY AND POLYTRAUMA. WORKUP REVEALED DIFFUSE SUBARACHNOID HEMORRHAGE WITH INTRAVENTRICULAR EXTENSION AND HYDROCEPHALUS. NONINVASIVE IMAGING IDENTIFIED A BASILAR ARTERY DISSECT ION WITH AN ASSOCIATED 2.4MM DISTAL BASILAR ARTERY ANEURYSM. THE PATIENT UNDERWENT UNCOMPLICATED PLACEMENT OF A SINGLE PED WITH SHIELD TECHNOLOGY SPANNING THE MIDBASILAR TO LEFT P2. DESPITE INITIAL RECOVERY, THE PATIENT ACUTELY DECLINED ON POSTPROCEDURE DAY 19. IMAGING REVEALED RERUPTURE OF THE DISSECTING ANEURYSM WITH EXTENSIVE SUBARACHNOID AND BRAINSTEM HEMORRHAGE. THE PATIENT DIED SHORTLY T HEREAFTER. A IN THE SECOND CASE RELATED DEATH A (B)(6) YR-OLD GIRL WITH A HISTORY OF RECURRENT PITUITARY BLASTOMA TREATED PREVIOUSLY WITH RESECTION, STEREOTACTIC RADIOSURGERY, AND CHEMOTHERAPY, PRESENTED WITH HEADACHE, SEIZURE, AND LEFT HEMIPARESIS. EMERGENT IMAGING REVEALED SUBARACHNOID HEMORRHAGE AND A 5MM RIGHT INTERNAL CAROTID ARTERY TERMINUS ANEURYSM. INTERVAL IMAGING 2 WEEKS POST PROCEDURE SHOWED NEW INTRAVENTRICULAR HEMORRHAGE AND ANEURYSMAL RECURRENCE. THIS RECURRENCE WAS TREATED WITH ADDITIONAL COIL EMBOLIZATION AND PIPELINE PLACEMENT. THE OPERATION WAS UNCOMPLICATED, AND THE PATIENT WOKE AT NEUROLOGIC BASELINE. HOWEVER, THE PATIENT DECLINED SUDDENLY THE FOLLOWING DAY. REPEAT HEAD CT REVEALED EXTENSIVE SUBARACHNOID, INTRAPARENCHYMAL, AND SUBDURAL HEMORRHAGES. THE PATIENT ULTIMATELY DIED SEVERAL DAYS LATER. A THIRD DEATH OCCURRED IN A PATIENT WITH MICROCEPHALIC OSTEODYSPLASTIC PRIMORDIAL DWARFISM TYPE II WITH MULTIPLE INTRACRANIAL ANEURYSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480956 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death