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
Entrapment of Device (1212); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); 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 11/16/2021 |
Event Type
malfunction
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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 along with non-medtronic 6fr 45cm sheath, a spider fx 0.014" guidewire and 6mm spider embolic protection during procedure to treat a little calcified soft tissue lesion in the right distal superficial femoral artery (sfa) with chronic total occlusion (cto-100%).The vessel was none tortuous.The vessel diameter and lesion length are 5mm - 5.2mm and 300mm+ respectively.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.Deployment issue occurred with the stent partially deployed.There was no damage to the deployment mechanism or device handle prior to deployment issue.The thumbscrew/lock-pin were checked prior to procedure.The lock-pin was removed after positioning, prior to rolling thumb wheel to deploy.The lesion was pre dilated with a 6mm nanocross pta balloon.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.It was reported that the deployment handle was disassembled by physician and staff, and inner wir e was pulled to complete deployment.Stent catheter was unable to be removed without removal of wire, so spider wire system was removed along with catheter.Sfa-pop were re-wired with 0.014" wire, and two additional overlapping stents were implanted to cover cto.The lesion was post dilated.There was no patient injury.
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Manufacturer Narrative
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Product analysis: the everflex entrust device was returned to medtronic investigation lab for evaluation.The device was returned coiled inside a biohazard bag in its pouch inside a biohazard bag.The device was returned with the handle opened and the pull wire broken, the proximal end of the inner lumen is kinked and there is guidewire (spider fx) stuck in device.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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