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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Obstruction/Occlusion (2422); Restenosis (4576)
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Event Date 08/09/2010 |
Event Type
Injury
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Manufacturer Narrative
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Endovascular treatment of femoropopliteal stenoses/occlusions with a silverhawk directional atherectomy device: immediate results and 12-month follow-up vascular and interventional radiology radiologia vascolare e interventistica radiol med (2010) 115:1208¿1218 doi 10.1007/s11547-010-0570-8 a3 majority gender medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Abstract purpose.This paper reports our immediate and 12-month follow-up results in the treatment of arterial stenoses/occlusions of the femoropopliteal region with the use of the silverhawk directional atherectomy device (ev3, usa).Materials and methods.In an 18-month period, we treated 18 patients (13 men, five women, age range 39¿81 years) with the silverhawk directional atherectomy device.Inclusion criteria were symptomatic femoropopliteal stenosis/insufficiency, nonresponsiveness to medical therapy, and rutherford categories 3¿5.Exclusion criteria were based on the preliminary colour doppler ultrasound (us) assessment and were plaque with a calcified component >50% and inadequate upstream and/or downstream vascular bed.Patients with severe vascular impairment, classified as transatlantic inter-society consensus (tasc) d, were also excluded.Results.The procedure was successfully completed in all cases, with evident recanalisation and sufficient wall remodelling.No major complication was observed.At assessment immediately after the procedure and over the following days, an improvement in clinical symptoms and in the rutherford scale was observed.Follow-up at 2 and 12 months identified one case of distal reocclusion subsequently treated with amputation, and two cases of restenosis (primary patency 79%) successfully treated with a repeat procedure (secondary patency 96%).Conclusions.The silverhawk directional atherectomy device proved to be an effective and safe tool in all our patients treated for f emoropopliteal stenosis/occlusion, with a significant improvement in both imaging findings and clinical signs and symptoms.
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