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); 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 03/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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Physician attempted to implant an everflex entrust self-expanding stent during treatment of a 150mm calcified lesion in the patient¿s superficial femoral artery (sfa).Artery diameter reported as 6mm.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without issue.Embolic protection was not used.It was reported the stent partially deployed at the target site within the patient vasculature.The thumbscrew/lock-pin was removed prior to attempted deployment.The stent ended up deploying fully by pin-and-pull action after removal of the handle.The stent remains in the patient.There were no attempts made to remove the stent.No deformation was noted to the deployed stent.The delivery system was safely removed.No vessel damage reported.No patient injury reported.
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Search Alerts/Recalls
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