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Model Number UNK-NV-SOLITAIRE |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problem
Vascular Dissection (3160)
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Event Date 04/11/2021 |
Event Type
Injury
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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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Event Description
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Medtronic received a report that the patient's artery became dissected during a thrombectomy and a solitaire fr could not be detached.The patient was undergoing treatment for a thrombus removal in the patient's right internal carotid artery/middle cerebral artery. patient vessel tortuosity was minimal.The stroke onset to reperfusion time was 4 hours.It was reported that after the thrombus was removed, it was found that the m1 segment was dissected.The stent supporting blood flow was normal, and the blood flow of the retracted stent was blocked, so it was decided to put in solitaire fr 6x30 stent.After placing it, the device couldn¿t be deployed, even after replacing the cable and using a new battery.The solitaire fr was removed and replaced with a 6x30 solitaire ab.According to the previous operation, it was deployed successfully after 40 seconds.The physician had attempted to detach the stent 3 times for 5-15 minutes each attempt.The detachment box and cable were new, and there was no damage noted to the box.The catheter tip was 2-3mm away from the detachment zone which was not against the vessel wall.A 20ml needle was used, and was placed in the muscle next to the puncture point.The detachment box displayed as indicated in the instructions for use (ifu).The pushwire was on a dry clean surface.The black cable was connected to the needle, and the red cable was connected to the pusher wire. the patient did not experience any injury or complications.The devices were prepared according to the ifu.
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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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Event Description
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Additional information received clarified that the first stent used in the procedure was the solitaire fr that could not be detached.
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Event Description
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Additional information received clarified that after the thrombus was removed, it was found that the m1 blood vessel was still narrow but not dissected.They continued to open it with the solitaire fr stent and opened it at the position.After the stent was retracted, the blood flow was blocked again, so they decided to deploy the stent.After the stent was placed in a narrow place, it couldn¿t be deployed.They replaced the cable and used a new battery, and it still couldn¿t be deployed, it could only be removed.The solitaire fr was replaced with the solitaire ab stent into it, according to the previous operation, and it was deployed successfully after 40 seconds.
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Manufacturer Narrative
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It was clarified that a only a single solitaire fr was used.This report is a duplicate of manufacturer report # 2029214-2021-00661.All future updates will be submitted in 2029214-2021-00661.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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