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Model Number FG19120-1030-1S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Vasoconstriction (2126); Nervous System Injury (2689); Hemorrhagic Stroke (4417); Embolism/Embolus (4438)
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Event Date 11/26/2023 |
Event Type
Injury
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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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Medtronic received a report that the patient developed complex neurological symptoms post-operative, resulting in multiple investigations and tests that found polymer emboli in the brain.Symptoms presented over the days, weeks, and months post-operative similarly to vasculitis and multiple tests and investigations were completed before finally doing a brain biopsy.Treatment was steroids, immunotherapy and other not made known to the manufacturer representative (rep) due to confidentiality.The patient is alive with injury.The patient suffered cerebral hemispherical hydrophilic polymer embolism/emboli after several months unwell in and out of hospital requiring steroids, brain biopsy (which confirmed polymer emboli) and will require several years of immunotherapy and steroids to manage condition.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.The access vessel was the internal carotid artery (ica).Ancillary devices include a stryker excelsior sl-10 st 2 tip (lot 24089060) microcatheter, terumo glide cath 5fr (lot: 230713) micro catheter.
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Event Description
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Additional information received reported the patient remains unwell, with ongoing medical care required.The patient had symptoms of stroke, vasospasm, and other non-specific neurological symptoms.The cause of the issue was not determined, but the customer assumes one of the catheters polymer jackets was compromised during the procedure.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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