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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intimal Dissection (1333); Occlusion (1984)
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Event Date 11/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported in the literature article, usefulness of the ¿non-slip element¿ percutaneous transluminal angioplasty balloon in the treatment of femoropopliteal arterial lesions, that a study was carried out to evaluate a new scoring balloon, the non-slip element (nse) percutaneous transluminal angioplasty (pta) balloon, in the treatment of femoropopliteal lesions by comparing angiographic dissection patterns to those of a conventional balloon over a 17 months period.This retrospective, single-centre study included 71 symptomatic patients with de novo femoropopliteal lesions <(><<)>20 cm long treated with balloon angioplasty.Thirty-four patients were treated with 3 inflations of an nse balloon and 37 patients were treated with a conventional balloon.In the 37 non-nse patients, angioplasty was performed on 3 patients using a conventional rapidcross balloon and the other 34 patients non-medtronic conventional balloons were used.Severe dissections were fewer and the total dissection length was shorter in the nse group.The bailout stenting rate was also lower in the nse group.There were no significant differences between the groups regarding lesion length, inflation time, or inflation pressure.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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