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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Medtronic received a report that the patient experienced a vascular access site hemorrhage post procedure.It was noted that on (b)(6) 2023 there was an episode of acute symptomatic hypotension with worsening right flank pain, hgb 10, on repeat 8.Ct showed large retroperitoneal bleeding (rp) bleed with no active extravasation.The event was treated with a blood transfusion and 1 liter 0/9% sodium chloride bolus infusion and manual compression.The event was recovered/resolved on (b)(6) 2023.The event did not result in new or worsening neurological deficits and did not result from a device deficiency.The event was not related to the disease under study.The event was assessed as casually related to the study procedure and probably related to the antiplatelet medication.Additional information was received that the patient was undergoing surgery for treatment of a saccular, side branch aneurysm of the right internal carotid artery c6 with a max diameter of 5.8mm and a 3.8mm neck diameter.Aneurysm done height was 5.8mm and width was 3.8mm.Parent artery distal to aneurysm was 3.2mm and proximal was 3.5mm.There was no stasis and completed neck coverage at the end of the procedure; raymond and roy class 3.The study device was successfully implanted and wall apposition was achieved with side branches covered by pipeline (opha, sha).There was no device flattening or twisting.Ancillary devices include navien 058 and phenom 027.
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