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Catalog Number SEPX-10-7-40-135 |
Device Problems
Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2021 |
Event Type
malfunction
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Event Description
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Physician was attempting to use the protégé rx self expanding stent to treat the common carotid artery.A non medtronic 8fr sheath and 300cm guidewire were used.A 5mm embolic protection device was used.There was no damage noted to packaging and no issue when removing the device from the hoop/tray.The device was prepped per the ifu with no issues.The thumbscrew was checked for securement prior to procedure. it was reported that there was deployment/partial deployment issue.The stent was successfully released after the lesion was prepared, the delivery rod could not be retracted, the stent could not be released, and could not be retracted, and then it was released forcefully.The stent was deployed after strong force.However, later radiography showed that there were obvious creases in the middle of the stent.Stent deployed to the target site.No patient injury reported.
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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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Manufacturer Narrative
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Product analysis: the protege rx device was returned to medtronic investigation lab for evaluation.The device was returned coiled inside a biohazard bag.The device was received with the proximal grip detached from the hypotube and with the outer shaft bunched under the strain relief.The deployed distal section of the inner shaft is kinked.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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Image review: image 1 appears to show the patient¿s vasculature.There is contrast in the artery and there appears to be a blockage visible.Image 2 appears to show a partially deployed stent.Image 3 appears to show a deployed stent that hasn¿t fully expanded with an inflated balloon inside the stent.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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Search Alerts/Recalls
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