COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY
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Catalog Number EVX35-06-150-120 |
Device Problems
Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2022 |
Event Type
malfunction
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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 procedure to treat a severely calcified lesion in the right mid superficial femoral artery (sfa) with chronic total occlusion (cto-100%).The vessel was severely tortuous.The vessel diameter and lesion length are 5mm and 120mm respectively.No embolic protection was used.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu with no issues identified.It was reported that partial deployment occurred.There was no damage to the deployment mechanism or device handle prior to deployment, it did not release properly.The thumbswitch/lock-pin was checked for securement prior to procedure.The lock-pin was removed before starting deployment.The lesion was pre dilated with a 5mm device.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.There were difficulties in deploying the stent, it was released manually but in this attempt the stent was deformed.There was no attempt to remove the stent.Deformation was noted at the time that an attempt was made to finish manually unlocking the device.Stent adjustment was not carried after initial flowering of stent.The deployment of the stent began before finishing the release of the lock in the delivery system, so it is necessary to try to release manually and that is where the stent presents deformity in the attempt.No action was taken as a result of the deformation.The delivery system was safely removed with no vessel damage reported.There was no patient injury reported.
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Manufacturer Narrative
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Image analysis the customer returned one image.Image 1: the image depicts what appears to be the patients vasculature system with what appears to be a deformed stent deployed, with a guidewire running through the 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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