MEDTRONIC IRELAND ENDURANT II BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Model Number ETBF2516C145EJ |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 01/26/2024 |
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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An endurant ii bifurcate stent graft was implanted during the endovascular treatment of a 47x53mm aaa.It was reported that during the index procedure the endurant ii stent graft was implanted in the left main.When removing the delivery system the tapered tip was recaptured however it wasn't recaptured with the graft cover.Post removal the physician realised it wasn't recaptured properly whilst in the patient and contrast was performed.Dissociation was suspected in the eia-cfa.A non -mdt limb was placed in the contralateral side leg, touch-up was performed and a non-mdt stent was placed in the left eia-cfa and the procedure was completed.Per the physician the cause of the event was user error.It was noted that the physician forgot to recapture the tip and noted that the main device peripheral end might not have opened properly, so the procedure was skipped due to concerns about whether it had been covered by the iia.No additional sequelae were reported and the patients is fine.
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Manufacturer Narrative
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Additional information received; it was confirmed that vascular injury occurred and a bare metal stent (bms) was placed.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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