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 Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2024 |
Event Type
malfunction
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Event Description
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An everflex entrust was intended to be implanted for the treatment of a calcified lesion in the distal region of the superficial femoral artery popliteal artery.The device was prepped as per the ifu with no issues identified.The lesion was pre-dilated with a 5mm pre-dilation device.The lock-pin was checked for securement and then removed prior to deployment of the stent.There was no resistance during delivery to the lesion and the device passed though a previously deployed stent.It was reported the device could not be deployed.The stent system and 0.014 non medtronic wire were removed as a unit.Device was safely removed from patient and intervention was required.No patient injury.Stent struts were visible upon removal.
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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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Manufacturer Narrative
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Product analysis the device was returned with the red safety tab out of the device, and there was a guidewire stuck in the device, the device was identified by the strain relief, the stent was still in the device and approx.1mm of the stent was exposed, the gold outer sheath was observed protruding from the red safety lock space, the guidewire was measured and measured as 0.014¿, the handle was dismantled, and the pull cable was observed to be attached to the deployment wheel and to the device.The gold inner sheath was observed to be kinked and bunched, the stent was unable to be deployed by using the manual deployment method.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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