COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY
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Catalog Number EVD35-06-150-120 |
Device Problems
Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/19/2022 |
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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A physician was attempting to implant an everflex entrust for the treatment of a 120mm calcified plaque lesion with chronic total occlusion in the left superficial femoral and artery popliteal artery.There was moderate calcification and tortuosity.The patient has tortuous iliacs.A 6fr non medtronic sheath and 0.035" non medtronic guidewire were used.The device was prepped as per the ifu with no issues identified.The lesion was pre-dilated with a 5x200 in.Pact admiral.The lock pin was removed prior to deployment.Resistance was encountered while advancing the device.It was reported the stent could not deploy. the strain relief was removed and the stent handle was separated.The gold colored isolation sheath was held in place while the remaining piece of thread was pulled on.This was unsuccessful in getting the stent to deploy.This was tried several times to no avail.Another arterial access was obtained in the same groin.A guidewire and catheter were used to get a buddy wire system in place.Once this was achieved the partially deployed stent and deployment catheter was pulled out with a guidewire in place under fluoroscopy.This was successful and no stent fragments remained.Another everflex entrust was delivered to the lesion and was successfully deployed with no issues.
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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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