MEDTRONIC IRELAND ENDURANT II STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
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Model Number UNK-CV-SR-ENDUR-II |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Inflammation (1932); Local Reaction (2035); Hypervolemia (2664)
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Event Date 12/14/2020 |
Event Type
Injury
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Event Description
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Endurant ii stent grafts were implanted during the endovascular treatment of infrarenal aaa on unknown dates.Non mdt stent grafts were also implanted.The following adverse events were reported: conversion to aortouniiliac graft and femorofemoral bypass, post implantation syndrome, side-effects to the contrast medium use, fluid overload, drain retention and minor wound bleeding.The cause of the adverse events are undetermined.
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Manufacturer Narrative
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Medtronic received the following information from a journal article entitled; factors affecting radiation exposure in endovascular repair of abdominal aortic aneurysms: a pilot study kakkos et al, international angiology 2021 april;40(2):125-30.Doi: 10.23736/s0392-9590.20.04508-3.Exact date of implant unknown.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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B5; additional information received : the author confirmed that there were no adverse events considered related to any of the endurant devices.Furthermore, it was said that the radiation exposure is related with the patient¿s anatomy, and the endurant device has always the most complicated anatomies.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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