Inadvertent Stent Retriever Detachment: A Multicenter Case Series and Review of Device Experience FDA Reports

Autor: Diogo C Haussen, Daniel Roy, R Novakovic, Hesham Masoud, Sonal Mehta, Dileep R. Yavagal, Thanh N. Nguyen, Michael G. Abraham, Ayman Quateen, Ajit S. Puri, Franklin A. Marden, Sudheer Ambekar, Tim W. Malisch, Coleman O. Martin, Alexander Norbash, Raul G Nogueira, William E. Holloway, Alain Weill, Daniela Iancu, Diego J. Lozano, Michael Chen
Rok vydání: 2015
Předmět:
Zdroj: Interventional Neurology. 4:75-82
ISSN: 1664-5545
1664-9737
DOI: 10.1159/000441920
Popis: Mechanical thrombectomy using retrievable stents or stent retriever devices has become the mainstay of intra-arterial therapy for acute ischemic stroke. The recent publication of a series of positive trials supporting intra-arterial therapy as standard of care for the treatment of large vessel occlusion will likely further increase stent retriever use. Rarely, premature stent detachment during thrombectomy may be encountered. In our multicenter case series, we found a rate of detachment of less than 1% (n = 7/1,067), and all were first-generation Solitaire FR devices. A review of the US Food and Drug Administration database of device experience yielded 90 individual adverse reports of detachment. There were 82, 1 and 7 detachments of Solitaire FR (first generation), Solitaire FR2 (second generation) and Trevo devices, respectively. We conclude with a brief overview of the technical and procedural considerations which may be helpful in avoiding this rare complication.
Databáze: OpenAIRE