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| Model Number SFR4-4-40-10 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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| Patient Problems
Stroke/CVA (1770); Death (1802); Hemorrhage, Cerebral (1889)
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| Event Date 05/29/2020 |
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Event Type
Death
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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 experienced a procedure and device related malignant stroke of the right middle cerebral artery on (b)(6) 2020 with a fatal outcome.Post-procedure non-contrast ct showed hypodensity with mass effect (malignant).No additional information was provided at the time of the report.
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Event Description
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Additional information received noted that there was no device malfunction.
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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.
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Manufacturer Narrative
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B5: event description: additional information.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 on 30jul2020: 84-year-old woman who, being previously asymptomatic, in the presence of her daughter, fell to the ground with left hemiparesis and drowsiness.Consequently, she was transferred to (b)(6) hospital, where cranial ct scan and ct angiography showed occlusion of distal segment of right ica with aspects 8.After contacting telemedicine stroke unit, treatment with rtpa was prescribed and, after airway protection by endotracheal intubation, she was transferred to the hospital to assess endovascular treatment.On arrival, patient was transferred directly to arteriography lab.First sequences confirmed presence of occlusion of m1 segment of right mca.First pass was performed with solitaire and distal aspiration with react, achieving tici 3.Consequently, treatment was completed with no complications, and patient was transferred to icu-trauma.Follow-up ct scan the next morning was recommended.Follow-up cranial ct scan showed subacute infarction affecting almost entire deep and superficial territory of right mca with risk of malignant course.Therefore, she was assessed by neurology department who reported that, in view of findings visualized on ct, and assessing benefit-risk taking into account the patient¿s context, in view of extensive infarction and patient¿s age, she would not be eligible for surgery with poor short-term prognosis.Patient was also assessed by neurosurgery department, who considered patient was not eligible for surgical treatment, decompressive craniectomy.During her stay in the unit, neurologically poor clinical progress with impaired level of consciousness, gcs drop of 4-5, pupils initially weakly reactive followed by bilateral nonreactive mydriasis, associated absence of corneal and cough reflexes although with some spontaneous respiration, performing extension movements with upper limbs.Transcranial doppler showed slow flow in both middle cerebral arteries with progressive ¿systolization¿ thereof.In past 12 hours, patient progressed to brain death with bilateral nonreactive mydriasis with complete absence of brainstem reflexes and no motor activity.
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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 core lab image review of ct done on (b)(6)2020 confirming previously noted infarct findings and described as "suspected pontine / mesencephalic infarct." it was determined the infarction could be in a new territory as baseline initial clot was at right mca-1.It was also noted that there were no pre-procedure images to compare.It was also noted in the report that a react-71 catheter was used in the procedure.
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Search Alerts/Recalls
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