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Catalog Number SEPX-8-6-40-135 |
Device Problems
Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2022 |
Event Type
malfunction
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Event Description
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A physician was attempting to implant a protege rx stent for the treatment of a plaque lesion with 80% stenosis in the mid common carotid artery.The degree of tortuosity and calcification was moderate.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was prepped as per the ifu with no issues identified.The lesion was pre-dilated.It was reported that resistance was encountered during delivery to the lesion and force was applied but the stent was unable to deploy.The lock pin had been checked for securement prior to the procedure and the pin had been removed before attempting to deploy the stent.The device did not pass through a previously deployed stent.During deployment in the body, it was found that the release handle was very tight and could not be completely deployed.Considering avoiding the intraoperative risks caused by the product, the operation was successfully completed after it was withdrawn and replaced with a new stent.There was no intervention r equired for removal of the device.The device was safely removed from the patient.Stent struts were exposed/visible on removal but unable to detach.After withdrawing the defective product, the surgeon checked the reason, tried to release it many times, and deployed it outside the body.No patient injury was 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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Product analysis: the device was returned with the touhy-borst tight.The protégé rx was received with the stent out of the device, stent was confirmed as 40mm with no abnormalities or biologics observed, 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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