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Model Number SFR4-4-40-10 |
Device Problems
Break (1069); Physical Resistance/Sticking (4012)
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Patient Problems
Thromboembolism (2654); Device Embedded In Tissue or Plaque (3165)
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Event Date 08/05/2021 |
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 during the thrombectomy, a stent was placed.It was noticed the clot had dislodged and clotted around the m2 area.It was decided to use the solitaire.While pulling it out, the solitaire became stuck in the carotid stent, and the wire broke.The solitaire stent was detached and left in the patient.The patient improved and was discharged two days after the case.
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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 reported that the clot was aspirated and the vessel was able to be opened.The patient did not experience any complications post-procedure, and were discharged the next day.It was clarified that the vessel occlusion started at the ica origin, and a carotid stent was placed before advancing the stent retriever.While retrieving the solitaire, it entangled with the carotid stent.As the physician pulled it out, the stent broke off from the wire, leaving the solitaire in.
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Manufacturer Narrative
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Ancillary device: precise pro - cordis (lot: 17994527).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.
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Event Description
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Additional information received reported the implanted stent was not a medtronic device.
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Search Alerts/Recalls
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