Inadvertent Detachment of a Retrievable Intracranial Stent: Review of Manufacturer and User Facility Device Experience.
Few systematic surveys have dealt with the potential procedural risks associated with the use of retrievable intracranial stents [Solitaire Flow Restoration (Solitaire FR)], which have become effective tools for recanalizing acutely occluded cerebral arteries. The aim of this study was to present the real-world experiences of Solitaire-FR-related adverse events by reviewing the MAUDE (Manufacturer and User Facility Device Experience) as published on the United States Food and Drug Administration website. In total, 85 adverse events related to the use of the Solitaire FR stent were reported between March 2012 and October 2014. In 80 patients these adverse events were attributable to inadvertent detachment of the device. Thirteen of these 80 patients (16%) died after the procedure. Morbidity data were available in 62 patients, among whom 11 (18%) had suffered a procedure-related injury. Detachment occurred at the first, second, and third pass in nine (21%), 21 (49%), and 13 (30%) of the 43 patients for whom this information was available, respectively. Resistance was perceived by the physician during retrieval of the device in 12 patients, and lesion characteristics were noted in 13. A rescue maneuver was reported in 20 (25%) of the 80 patients in whom the adverse event was attributable to detachment of the device, resulting in flow reestablishment in 13 (65%). The risk of inadvertent detachment during stent retrieval cannot be overemphasized in real-world scenarios, and careful consideration of the "dos and don'ts" is essential for the achievement of a safe procedure.
Department of Radiology, The Armed Forces Capital Hospital, Sungnam, Korea.
Sang
S
Yub Lee
Department of Radiology ysw10adest@cu.ac.kr.
Sung
S
Won Youn
Department of Radiology.
Ho
H
Kyun Kim
Department of Neurology, Catholic University of Daegu Medical School, Daegu, Korea.
Young
Y
Rok Do
D015984:Causality; D002536:Cerebral Arteries / Q000293:injuries*; D002548:Cerebral Revascularization / Q000295:instrumentation* / Q000379:methods; D020878:Device Removal / Q000295:instrumentation; D057510:Endovascular Procedures / Q000295:instrumentation; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis; D005548:Foreign-Body Migration / Q000453:epidemiology* / Q000209:etiology; D006801:Humans; D015994:Incidence; D020767:Intracranial Thrombosis / Q000453:epidemiology / Q000209:etiology / Q000628:therapy; D061185:Mechanical Thrombolysis / Q000295:instrumentation; D056910:Republic of Korea / Q000453:epidemiology; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents / Q000009:adverse effects* / Q000706:statistics & numerical data; D020521:Stroke / Q000517:prevention & control; D015996:Survival Rate; D061205:Vascular Calcification / Q000453:epidemiology / Q000209:etiology / Q000628:therapy; D057772:Vascular System Injuries / Q000453:epidemiology* / Q000209:etiology / Q000628:therapy
acute stroke; device failure; endovascular procedure; intraoperative complication; safety management; stent