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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During the index procedure one resolute onyx drug eluting stent was implanted in the lmca.During the procedure three nc euphora balloons and one euphora balloon were also used to treat the lmca.A resolute onyx drug eluting stent, launcher guide catheter, two euphora balloons and three nc euphora balloons were used to treat another lesion, the cx.During the treatment of the cx a plaque shift occurred in the ostial lad and during the treatment of the lcma a plaque disruption occurred at the distal edge of the 2.5 x 15mm stent in the coronary artery.Another overlapping resolute onyx drug eluting stent was implanted to treat the plaque shift.The patient was taking dual antiplatelet therapy within 24 hours prior to the event.It was stated that it could not be confirmed if any/which devices could have caused or contributed to the ae.The patient recovered.
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