BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 13467462 · Received February 6, 2022

    Report

    Report Number
    2029214-2022-00163
    Event Type
    Injury
    Date Received
    February 6, 2022
    Date of Event
    February 12, 2020
    Report Date
    February 6, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DIETRICH, P., GRAVIUS, A., MÜHL-BENNINGHAUS, R., YILMAZ, U., KETTNER, M., BOMBERG, H., REITH, W., SIMGEN, A. (2020). SINGLE CENTER EXPERIENCE IN STENT-ASSISTED COILING OF COMPLEX INTRACRANIAL ANEURYSMS USING LOW-PROFILE STENTS. CLINICAL NEURORADIOLOGY, 31(1), 99¿106. HTTPS://DOI.ORG/10.1007/S00062-020-00883-5. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DIETRICH, P., GRAVIUS, A., MÜHL-BENNINGHAUS, R., YILMAZ, U., KETTNER, M., BOMBERG, H., REITH, W., SIMGEN, A. (2020). SINGLE CENTER EXPERIENCE IN STENT-ASSISTED COILING OF COMPLEX INTRACRANIAL ANEURYSMS USING LOW-PROFILE STENTS. CLINICAL NEURORADIOLOGY, 31(1), 99¿106. HTTPS://DOI.ORG/10.1007/S00062-020-00883-5. SUMMARY: THE INTRODUCTION OF LOW-PROFILE STENT SYSTEMS HAS BROADENED AND FACILITATED THE TREATMENT OF COMPLEX INTRACRANIAL ANEURYSMS. THIS RETROSPECTIVE CASE SERIES STUDY WAS CONDUCTED TO ASSESS AND COMPARE THE CLINICAL AND ANGIOGRAPHIC OUTCOMES OF PATIENTS WITH COMPLEX INTRACRANIAL ANEURYSMS WHO WERE TREATED WITH ACCLINO® (AS) AND ACCLINO® FLEX STENTS (AFS). IDENTIFIED EVENTS: 5 PATIENTS HAD STROKES. 2 PATIENTS HAD HEMORRHAGES. 1 PATIENT HAD AN IN-STENT STENOSIS. 1 PATIENT HAD A STENT OCCLUSION. 2 PATIENTS HAD STENT THROMBOSES. IN ONE OF THE CASES THE IN-STENT THROMBUS FORMATION UNDER DUAL ANTIPLATELET MEDICATION WAS OBSERVED IN THE CONTROL SERIES AT THE END OF THE INTERVENTION. 2 PATIENTS HAD PROCEDURAL ANEURYSM PERFORATION AND ONE TOOK PLACE IN AN ALREADY TREATED ANEURYSM. THE PERFORATIONS HAPPENED WHILE PUSHING THE COILS INTO THE ANEURYSMAL SAC. BOTH ANEURYSM RUPTURES COULD BE RAPIDLY OCCLUDED AND THE PATIENT'S HAD NO CLINICAL SEQUELAE. TWO PATIENTS HAD POST-PROCEDURE SMALL, PUNCTUATE INFARCTS IN THE MEDIA TERRITORY. BOTH PATIENTS SHOWED SUCCESSFUL DEVELOPMENT AND RECOVERED FULLY. ONE PATIENT WHO HAD A SAH CAUSED BY A RUPTURED BASILAR ARTERY ANEURYSM SUFFERED AFTER STENT-ASSISTED RECOILING A SMALL, DOT-LIKE INFARCT IN THE CEREBELLAR HEMISPHERE WITH NO CHANGE IN MRS. ONE PATIENT SUFFERED AN INFARCTION OF THE LEFT POSTERIOR CEREBRAL ARTERY AFTER ENDOVASCULAR TREATMENT OF A GIANT BASILAR ARTERY ANEURYSM. THE PATIENT DEVELOPED AN OBSTRUCTIVE HYDROCEPHALUS WHICH REQUIRED A SHUNT IMPLANT IN THE CLINICAL COURSE. 8 PATIENTS HAD INCOMPLETE OCCLUSION. 37 PATIENTS HAD A NECK REMNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505375 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention