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
Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907); Material Deformation (2976)
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Patient Problem
Hematoma (1884)
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Event Date 06/12/2023 |
Event Type
malfunction
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Event Description
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Physician was attempting to use an everflex entrust self-expanding stent along with a 6fr non-medtronic sheath and a 0.035 non-medtronic guidewire during treatment of fibrous plaque lesion in the patients right mid proximal superficial femoral artery (sfa).Moderate vessel tortuosity and moderate vessel calcification are reported.Artery diameter reported as 6mm.Lesion exhibited 30% stenosis.Embolic protection was not used.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues identified.The lesion was pre-dilated with a 6mm pre-dilation device.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.Inaccurate delivery is reported.There was sufficient distal landing zone.The delivery catheter did catch on stent upon withdrawal.Stent waselongated from 150mm to 250mm.Difficulty removing device following stent deployment is also reported.The handle broke, string broke and then couldn¿t find string.This issue is reported for 2 stents.Physician used a bigger sheath over undeployed stent sheath.A hematoma is reported.
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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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Additional information: this event was previously reported through regulatory rep #: 2183870-2023-00219 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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