MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II AUI STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number	ETUF2514C102E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: e tlw1628c93e, serial/lot #: (b)(4), ubd: 08-may-2021, udi#: (b)(4).Information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii aui stent grant and limb were implanted in the endovascular treatment of a abdominal aortic aneurysm and occlusive disease.It was reported the patient presented emergently 3 and a half months later with a cold leg.A ct performed showed a clot was present distally and occluded the stent in the sfa all the way to the popliteal.Intervention was performed, the aui with a etuf 23x14x102 and extended down to the leia with a 16x10 limb and then did a bypass to the popliteal.This resolved the event.No cause was reported.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
As per the physician the cause of the event was the patients poor outflow.It was said the etuf2514c102e stent graft was not occluded but had a large amount of thrombus burden inside the graft.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.
Additional Manufacturer Narrative
Product analysis conclusion the reported thrombus and vessel occlusion was confirmed on the films provided.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.It is likely that the calcified and narrow distal vessel anatomy was a factor in the occlusion observed due to poor distal run off.Other possible contributors to vessel occlusion, considering the large amount of thrombus observed throughout the stent graft, include an unknown coagulopathy that is now presenting.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.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11731090
• Report Number: 9612164-2021-01668
• Device Sequence Number: 4219882
• Product Code: MIH
• UDI-Device Identifier: 00643169232570
• UDI-Public: 00643169232570
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2022
• Device Model Number: ETUF2514C102E
• Device Catalogue Number: ETUF2514C102E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/10/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/07/2021; 07/01/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/01/2021; 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10."
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 56 YR