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Device Malfunction in Endovascular Treatment of Intracranial Aneurysms: Shared Responsibilities of Physician and Manufacturer

Device Malfunction in Endovascular Treatment of Intracranial Aneurysms: Shared Responsibilities... ... the war is too important to leave it to the generals, the medicine is too important to leave it to the doctors, the science is too important to leave it to the scientist... In this issue of the AJNR , Kwon et al describe "technical problems associated with new designs of Guglielmi Detachable coil [GDC]"; namely, device malfunction, such as the spontaneous detachment of GDC coils, coil backsliding into the microcatheter, and protrusion of small proximal parts of coils into the parent vessels after detachment. Only 12 events were reported out of many coils inserted. Unfortunately, the exact number of total coils used is not provided. Kwon et al reported these events in 10 (14.5%) of 69 recently treated patients. None of those patients had an adverse clinical outcome after endovascular treatment. The authors propose that the malfunctions they encountered are associated with the new SynerG GDC system (Boston Scientific/Target, Fremont, CA), particularly with the subtype, the stretch-resistant SR. Other complications, such as thromboembolism, aneurysmal rupture, coil migration, and coil stretching, were excluded from this report. The authors present a nonstandard in vitro evaluation of both the GDC system and the new SynerG GDC system in which http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Neuroradiology American Journal of Neuroradiology

Device Malfunction in Endovascular Treatment of Intracranial Aneurysms: Shared Responsibilities of Physician and Manufacturer

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Publisher
American Journal of Neuroradiology
Copyright
Copyright © 2010 by the American Society of Neuroradiology.
ISSN
0195-6108
eISSN
1936-959X
Publisher site
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Abstract

... the war is too important to leave it to the generals, the medicine is too important to leave it to the doctors, the science is too important to leave it to the scientist... In this issue of the AJNR , Kwon et al describe "technical problems associated with new designs of Guglielmi Detachable coil [GDC]"; namely, device malfunction, such as the spontaneous detachment of GDC coils, coil backsliding into the microcatheter, and protrusion of small proximal parts of coils into the parent vessels after detachment. Only 12 events were reported out of many coils inserted. Unfortunately, the exact number of total coils used is not provided. Kwon et al reported these events in 10 (14.5%) of 69 recently treated patients. None of those patients had an adverse clinical outcome after endovascular treatment. The authors propose that the malfunctions they encountered are associated with the new SynerG GDC system (Boston Scientific/Target, Fremont, CA), particularly with the subtype, the stretch-resistant SR. Other complications, such as thromboembolism, aneurysmal rupture, coil migration, and coil stretching, were excluded from this report. The authors present a nonstandard in vitro evaluation of both the GDC system and the new SynerG GDC system in which

Journal

American Journal of Neuroradiology – American Journal of Neuroradiology

Published: Sep 1, 2002

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