MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED3-027-450-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 07/18/2021 |
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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It was reported that the patient experienced a headache on (b)(6) 2021.They were instructed to take percocet analgesics as needed for 10 days.There was no device malfunction alleged or identified.Post-procedure angiographic results showed raymond and roy class 1, neck coverage achieved, and wall apposition achieved.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left internal carotid artery (ica) c5 with a max diameter of 6.6 mm and a 6.0 mm neck diameter.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level of adp 14 asa 03 maximal aggregation.Additional information received reported according to the site- headache was recorded erroneously.Percocet was prescribed for pain in the abdomen which is not related to the device, probably related to the procedure, not life threatening.Prolonged hospitalization.Corrected hospitalization summary will be provided.
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Event Description
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Mdr decision corrected to not reportable.No additional supplemental reports are required unless additional information received indicates reportable event.
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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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