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

Model Number	ETLW1624C124E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
An endurant ii stent graft system was implanted in the endovascular treatment of a ruptured aaa on (b)(6) 2021.  it was reported that when the patient returned for follow-up, on (b)(6) 2022, the patient was complaining of claudication.A cta and angiography was performed which showed the contralateral limb was completely thrombosed.A thrombectomy was then performed.The physician has not determined a root cause for the occlusion.It was confirmed the limbs with sn: (b)(4) were on the contralateral side.During the initial procedure, proper distal seal was not achieved and extensions needed to be placed inside the flared limb, with a flared limb.These limbs noted are those that were placed on the contra side-which is the side where occlusion was reported.It was reported that during the initial procedure on (b)(6) 2021, an etlw1624c124e was placed on the contra and ipsilateral limb.Unfor tunately neither of these limbs achieved distal seal.Therefore an etlw1614c93e limb was placed as an extension additionally on each side.At the end of the procedure distal seal was accomplished on both the contralateral and ipsilateral limbs.It was confirmed only the 2 limbs on the contralateral side were involved in the occlusion.The 2 limbs on the right side remain fully patent per the physician.No additional clinical sequalae were provided and the patient will be monitored.The patient still reports some residual claudication. .

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16136495
• Report Number: 9612164-2023-00129
• Device Sequence Number: 20494434
• Product Code: MIH
• UDI-Device Identifier: 00643169467507
• UDI-Public: 00643169467507
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2022
• Device Model Number: ETLW1624C124E
• Device Catalogue Number: ETLW1624C124E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/11/2023
• Date Device Manufactured: 02/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 57 YR
• Patient Sex: Male