COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY
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Model Number EVD35-06-150-120 |
Device Problems
Fracture (1260); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)
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Patient Problems
Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/12/2020 |
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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Physician was attempting to use an everflex entrust self-expanding stent during procedure to treat a little calcified lesion in the mid superficial femoral artery (sfa) with chronic total occlusion (cto-100%).The device was prepped per ifu with no issues identified.There was no damage to device packaging.There was no issue when removing device from hoop/tray.Inaccurate delivery occurred due to partial deployment.There was insufficient distal landing zone.The lesion was pre dilated using 5mm balloon.The device did not pass through a previously deployed stent.There was no resistance while advancing device.It was reported that 50mm of stent deployed and then there was a pop in the handle and the deployment wheel would spin but the stent would not deploy.Physician pulled the stent catheter out and the stent broke as a result.Physician deployed another stent over the fractured stent to secure it in place.The stent catheter was pulled back, the stent broke and the catheter was removed.There was no further patient injury reported.
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Manufacturer Narrative
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Additional information: the thumbscrew/lock-pin was checked for securement prior to procedure.Lock pin was removed.No vessel damage was noted.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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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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