COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY
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Catalog Number EVX35-05-150-080 |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2023 |
Event Type
Injury
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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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Event Description
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Physician was attempting to use an everflex entrust self-expanding stent during treatment of a lesion in the patients right mid superficial femoral artery (sfa), the target lesion was the atherosclerosis in the sfa right.The diameter of the artery was 5mm and the the lesion length was 200mm.50% tortuosity, 90% stenosis and 90% calcification was reported.Embolic protection was not used.The device was passed through a previously- deployed stent.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues identified.There was no a resistance when advancing the device and no excessive force was used.The lesion was pre dilated with 5mm and 6mm balloons.Stent deformation and fractur occurred during deployment of the stent.Stent opened after 5 cm break.There was no embolization of any component.The length of deployed stent in vessel was 15cm.The detached portion of device remains in the patient.A new stent was successfully implanted in the stent to complete procedure.No further patient injury reported.
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Manufacturer Narrative
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Image analysis: the customer returned 9 images for evaluation.Images #1-5 confirm that flow was restored with the implanted stent.Images #6-9 appear to show the pre-treated 90% sfa and images.The length of the implanted stent and detached portion were unclear in the images provided.Additional information: the second stent was implanted due tot he issue with the first one stent.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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