COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY
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Catalog Number EVD35-06-150-150 |
Device Problems
Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/22/2024 |
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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A physician was implanting an everflex entrust during treatment of a lesion in the proximal region of the right superficial femoral artery (sfa).The device was prepped as per the ifu with no issues identified.The lesion was pre-dilated with a 6mm balloon.The lock-pin was removed prior to deployment. the device was backloaded over the 0.035" guidewire.The physician advanced the device into position within the right sfa and removed and discarded the locking pin.The physician slowly rotated the thumbwheel and the stent started to deploy.After a portion of the stent was deployed, it was noted that the thumbwheel was rotating but the stent was no longer being deployed.The physician was instructed to open the housing that contained the thumbwheel and to use the deployment system as a "pinch and pull deployment system".After starting the "pinch and pull", the physician noted that the stent was migrating proximally.At this point, it was decided to abort the deployment of the stent.A vascular surgeon was called to take the patient went to the or with the stent partially deployed.The vascular surgeon successfully deployed the stent within the patient's right sfa.
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Manufacturer Narrative
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Update on (b)(6) 2024: no resistance was noted during advancement of the deployment system.The stent was still on the deployment system when the stent migrated proximally.The delivery system was safely removed.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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Product analysis the device was returned dismantled.No stent returned with the device the stent size was confirmed from the strain relief several kinks were observed on the silver-coloured outer sheath at approx.17cm, 25cm, 28cm and 48cm from the distal end of the device, due to the condition of the returned device no functional testing could be carried out.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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