BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON

    MDR report key: 13063852 · Received December 22, 2021

    Report

    Report Number
    2029214-2021-01664
    Event Type
    Death
    Date Received
    December 22, 2021
    Date of Event
    July 1, 2016
    Report Date
    December 22, 2021
    Manufacturer
    EV3 INC
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED TO INFORMATION REPORTED IN REGULATORY REPORT 2029214-2021-01657. REPORTED PATIENT AGE (52 YEARS) IS REPRESENTATIVE OF THE MEAN AGE FOR ALL PATIENTS INCLUDED IN THE STUDY. REPORTED PATIENT SEX (FEMALE) IS REPRESENTATIVE OF THE MAJORITY (70.4%) OF PATIENTS INCLUDED IN THE STUDY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ZHANG J, YU M, LV X. ENDOVASCULAR TREATMENT OF BLOOD BLISTER-LIKE ANEURYSMS OF INTERNAL CAROTID ARTERY: STENT-ASSISTED COILING AND PIPELINE FLOW DIVERSION. JOURNAL OF CLINICAL NEUROSCIENCE, 90 (2021) 8-13. HTTPS://DOI.ORG/10.1016/J.JOCN.2021.04.040. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND DESCRIBED RETROSPECTIVE STUDY OF 27 PATIENTS WHO UNDERWENT ENDOVASCULAR TREATMENT WITH STENT-ASSISTED COILING OR PIPELINE FLOW DIVERSION TO TREAT SUBARACHNOID HEMORRHAGE (SAH) DUE TO RUPTURE OF INTERNAL CAROTID ARTERY BLOOD BLISTER-LIKE ANEURYSMS FROM JULY 2016 THROUGH JULY 2020. A PROXIMAL STENOSIS CAUSED BY ANGIOPATHOLOGY ADJACENT TO ANEURYSMS WERE FOUND ON INTERNAL CAROTID ARTERY ANGIOGRAMS IN ALL 27 CASES. THE ANGIOPATHOLOGY COMBINING WITH THE ANEURYSMS IMPLEMENT THAT ACUTE DISSECTION OF THE SUPRACLINOID SEGMENT OF THE INTERNAL CAROTID ARTERY INDICATED THE PATHOGENESIS OF BLOOD BLISTER-LIKE ANEURYSM FORMATION.   ALL ANEURYSMS WERE TREATED SUCCESSFULLY WITH ALLEVIATION OF THE ADJACENT ANGIOPATHOLOGY AFTER STENTING ON ANGIOGRAMS. DURING 1 TO 12 MONTHS (MEAN 3.5 MONTHS) ANGIOGRAPHIC FOLLOWUP, COMPLETE ANEURYSM OBLITERATION WITHOUT ADJACENT STENOSIS WERE FOUND IN 25(92.6%) PATIENTS. THE ENTERPRISE STENT PATIENT EXPERIENCED POSTOPERATIVE REBLEEDING AT ONE WEEK HOSPITAL DAY AND THE ANEURYSM WAS RETREATED WITH COILS. ONE LVIS PATIENT SHOWED ANEURYSM RECANALIZATION AT 3 MONTHS FOLLOW-UP AND RETREATED WITH COILS AND ANOTHER LVIS STENT. THE RECURRENT RATE WAS 7.4%(2/27) IN OUR PATIENTS. THERE WAS NO RECURRENT BBLA IN FLOW DIVERSION PATIENTS. DURING 1¿12 MONTHS (MEAN 3.5 MONTHS) CLINICAL FOLLOW-UP, FAVORABLE CLINICAL MRS 0 AND 1 WAS OBSERVED IN 23(85.2%) PATIENTS, MRS 2 IN 3(11.1%) PATIENTS AND 1(3.7%) DEATH CAUSED BY COEXISTING GIANT BRAIN ARTERIOVENOUS MALFORMATION RUPTURE. ONE PATIENT PRESENTED WITH NON-OCCULT HYDROSTATIC HYDROCEPHALUS. NO PATIENT DEVELOPED CLINICALLY SIGNIFICANT LARGE VESSEL VASOSPASM. CONTINUOUS CEREBROSPINAL FLUID DIVERSION WAS PERFORMED IN THE 1 PATIENT PRESENTING WITH HYDROSTATIC HYDROCEPHALUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963521 ECHELON CATHETER, CONTINUOUS FLUSH KRA EV3 INC UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Death