BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 10128794 · Received June 8, 2020

    Report

    Report Number
    2029214-2020-00524
    Event Type
    Death
    Date Received
    June 8, 2020
    Date of Event
    June 19, 2013
    Report Date
    June 8, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    STEPHAN MECKEL, WILLIAM MCAULIFFE, DAVID FIORELLA, CHRISTIAN A. TASCHNER, CONSTANTINE PHATOUROS, TIMOTHY JOHN PHILLIPS, PAUL VASAK, MARTIN SCHUMACHER, JOACHIM KLISCH. ENDOVASCULAR TREATMENT OF COMPLEX ANEURYSMS AT THE VERTEBROBASILAR JUNCTION WITH FLOW-DIVERTING STENTS: INITIAL EXPERIENCE. NEUROSURGER 73 (2013). DOI: 10.1227/01.NEU.0000431472.71913.07. BACKGROUND: LARGE OR GIANT COMPLEX VERTEBROBASILAR JUNCTION ANEURYSMS HAVE A DISMAL NATURAL HISTORY AND ARE OFTEN CHALLENGING TO TREAT WITH STANDARD ENDOVASCULAR OR NEUROSURGICAL TECHNIQUES. OBJECTIVE: TO REPORT INITIAL EXPERIENCE WITH ENDOVASCULAR TREATMENT OF THESE ANEURYSMS USING FLOW-DIVERTING STENTS (FDS). METHODS: TEN PATIENTS WITH FDS TREATMENT OF COMPLEX VERTEBROBASILAR JUNCTION ANEURYSMS WERE COLLECTED FROM 4 LARGE CEREBROVASCULAR CENTERS. CLINICAL/ANGIOGRAPHIC PRESENTATION AND OUTCOME WERE RETROSPECTIVELY ANALYZED. RESULTS: OF 10 ANEURYSMS, 7 PRESENTED WITH BRAINSTEM COMPRESSION, 2 WITH ISCHEMIA, AND 1 WITH SUBARACHNOID HEMORRHAGE, AND 3 WERE RECURRENT AFTER STENT-ASSISTED TREATMENTS. EIGHT WERE GIANT. MORPHOLOGY WAS FUSIFORM IN 5, FUSIFORM DISSECTING IN 1, AND MULTILOBULATED SACCULAR IN 4. SIX WERE PARTIALLY THROMBOSED. IN ADDITION TO FDS (MEAN NUMBER OF DEVICES, 3.9; RANGE, 1-9), CONTRALATERAL VERTEBRAL ARTERY SACRIFICE AND ADJUNCTIVE COILING WERE PERFORMED IN 9 AND 5 OF THE 10 PATIENTS, RESPECTIVELY. AT FOLLOW-UP, 5 OF 10 WERE COMPLETELY OCCLUDED, 4 SHOWED MINIMAL RESIDUAL FILLING, AND 1 WAS RETREATED WITH AN ADDITIONAL FDS. POSTINTERVENTIONALLY, WORSENING MASS EFFECT AND ISCHEMIC COMPLICATIONS WERE SEEN IN 2 AND 4 OF 10, RESPECTIVELY. CLINICAL OUTCOME WAS GOOD IN 6 (MODIFIED RANKIN SCALE SCORE, 0-2). FOUR FATALITIES WERE RELATED TO SEQUELAE OF SUBARACHNOID HEMORRHAGE, LATE FDS THROMBOSIS, PROGRESSIVE MASS EFFECT, AND DELAYED INTRACRANIAL HEMORRHAGE. CONCLUSION: FDS MAY BE USED TO TREAT COMPLEX VERTEBROBASILAR JUNCTION ANEURYSMS WITH OVERALL GOOD ANGIOGRAPHIC OUTCOME. A COMBINED RECONSTRUCTIVE/DECONSTRUCTIVE APPROACH APPEARS USEFUL TO AVOID ENDOLEAKS. FDS STRATEGIES, LIKE OTHER ENDOVASCULAR AND NEUROSURGICAL APPROACHES TO THESE LESIONS, ARE ASSOCIATED WITH SIGNIFICANT RISK AND THEREFORE SHOULD BE RESERVED FOR THOSE CASES IN WHICH ALTERNATIVE APPROACHES EITHER ARE DEEMED UNSAFE OR ARE LIKELY TO BE INEFFECTIVE. REPORTED EVENTS. - (CASE 7) A (B)(6) YEAR OLD MALE UNDERWENT SURGERY TO TREAT A GIANT FUSIFORM ANEURYSM WHO BEGAN TO DETERIORATE CLINICALLY WITH PROGRESSIVE DIPLOPIA, GAIT INSTABILITY, HEADACHE, AND DIZZINESS 5 MONTHS AFTER THE UNCOMPLICATED FDS PROCEDURE AND DESPITE PROGRESSIVE ANEURYSM THROMBOSIS. MAGNETIC RESONANCE DEMONSTRATED SLIGHT ENLARGEMENT OF THE ANEURYSM-THROMBUS MASS WITH PROGRESSION OF ASSOCIATED BRAINSTEM EDEMA. THE PATIENT WAS TREATED WITH INTRAVENOUS DEXAMETHASONE. BECAUSE RESIDUAL FILLING ALONG THE FDS CONSTRUCT WAS SEEN, AN ADDITIONAL PED WAS PLACED OVER THE ENTRY REMNANT. HOWEVER, THE PATIENT CONTINUED TO DEMONSTRATE GRADUAL NEUROLOGICAL DETERIORATION WITH PROGRESSIVE QUADRIPARESIS, DYSPHAGIA, AND LETHARGY AND ULTIMATELY DIED 7 MONTHS AFTER THE ORIGINAL TREATMENT. - (CASE 5) A (B)(6) YEAR OLD MALE EXPERIENCED A DELAYED IN-STENT THROMBOSIS THAT OCCURRED IN 1 GIANT FUSIFORM ANEURYSM TREATED WITH 9 OVERLAPPING PEDS 11 MONTHS AFTER THE PROCEDURE. TWO WEEKS EARLIER, CONTROL DIGITAL SUBTRACTION ANGIOGRAPHY HAD DEMONSTRATED A LARGELY THROMBOSED ANEURYSM WITH MINIMAL RESIDUAL INFLOW, AND CLOPIDOGREL HAD BEEN DISCONTINUED. DESPITE SUCCESSFUL INTRAVENOUS (EPTIFIBATIDE), INTRA-ARTERIAL (RECOMBINANT TISSUE-TYPE PLASMINOGEN ACTIVATOR) THROMBOLYSIS, MECHANICAL THROMBECTOMY, AND SURGICAL POSTERIOR FOSSA DECOMPRESSION, THE PATIENT ULTIMATELY DIED OF LARGE POSTERIOR CIRCULATION INFARCTS. - (CASE 8) A (B)(6) YEAR OLD MALE UNDERWENT SURGERY TO TREAT A GIANT FUSIFORM ANEURYSM. THE PATIENT HAD MULTIPLE VASCULAR RISK FACTORS AND DIED DUE TO DELAYED THALAMIC HEMORRHAGE OCCURRING 38 DAYS AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594357 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE NOT-REP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death