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Model Number UNK-NV-FG |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intracranial Hemorrhage (1891); Pseudoaneurysm (2605)
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Event Date 02/06/2024 |
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 had a vascular access site pseudoaneurysm reported by the site.Upon cec review of the event on 06-feb-2024, a separate adverse event (ae) was identified for vascular access site hemorrhage that was causally related to the study procedure.It is unknown if there were any impacts to the patient or if there was any additional medical intervention required to prevent permanent injury or impairment.Additional information was received that the site reported a separate event of "hematoma on the right hip" and provided description of " large subcutaneous hematoma on the right hip, not painful to palpate.The patient fell in garden before stroke.Appears after the thrombolysis.X-ray of the right hip was done after the thrombectomy and result is no fracture.A compressive pansement is done".Per site, it was not an access site hemorrhage, not related to procedure, devices utilized or index condition, but probable related to an underlying condition or disease.It was noted that diagnostic imaging (x-ray), blood transfusion, and compressive bandage was required to address the adverse events.The event was not life threatening and hospitalization was not prolonged.The event led to serious deterioration in the health of the subject, as defined by: medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function.
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Search Alerts/Recalls
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