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Model Number UNK-NV-FG |
Device Problems
Difficult to Remove (1528); Physical Resistance/Sticking (4012)
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Patient Problem
Embolism/Embolus (4438)
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Event Date 09/16/2022 |
Event Type
malfunction
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Event Description
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Medtronic received information regarding system with a phenom 21 catheter, react-71 aspiration catheter, and solitaire that had resi stance during retrieval and the react catheter was noted to be stretched and torn upon removal.The patient underwent a procedure to treat tandem lesions - angioplasty to treat extracranial right internal carotid artery stenosis and thrombectomy of a middle cerebral artery (mca) occlusion.It was reported that the devices were prepared and catheter flushed per the instructions for use (ifu).After performing angioplasty of the stenosis in order to gain access to reach the intracranial territory, the surgeon ascended the triaxial system.After crossing the occlusion, the solitaire was deployed.It was impossible to ascend the react-71 catheter to the occlusion location.After thrombectomy, it was difficult to remove both the phenom 21 catheter and the react-71 catheter along with the solitaire but retrieval was finally successful.After removal of the system, a tear and stretching of the react catheter was observed.It was noted there was a distal embolization fragment toward the external carotid artery with no associated patient symptoms.The physician believed that the proximal stenosis played a significant role in the difficulties removing the catheters but was unsure how the damage was so significant to the react-71.
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Manufacturer Narrative
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Associated with rr #: 2029214-2022-01614.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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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 the vessel tortuosity was moderate.
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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 per site entry - "subject suffered no effects".
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Search Alerts/Recalls
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