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

Model Number	ETCF2828C49E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant iis stent graft system (esbf2814c103e) and endurant limbs (etlw1616c93e & etlw1616c124e) was implanted during the endovascular treatment of a 62mm abdominal aortic aneurysm on (b)(6) 2023.The proximal aortic neck was 23mm and 26mm in length with mild neck calcification.Mild left and right iliac calcification was noted.It was reported 4 days post the index procedure, the patient presented emergently with a cold leg.Follow-up imaging revealed a limb thrombosis of the left limb (etlw1616c124e).On 05-dec-2023, open aorto bifem intervention to treat the limb thrombosis was performed.During the procedure, both endurant limbs (etlw1616c124e & etlw1616c93e) were explanted, and the endurant iis (esbf2814c103e) was partially explanted, leaving the suprarenal fixations in place and 2/3s of the main body bifurcate.Two endurant ii aortic cuffs (etcf2828c49e & etcf3232c49e) were implanted to seal the proximal neck atthe renal arteries.However, on (b)(6) 2023 the patient continued to experience proximal leakage despite the aorto bifem procedure and cuff implants.The physician opted to explant both of the cuffs and non mdt grafts were implanted.Per the physician the cause of the limb thrombosis and type ia endoleak is undetermined.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Concomitant medical product: section d information references the main component of the system.Other relevant device(s) are: product id: etcf3232c49e, serial/lot #: (b)(6) ubd: 28-feb-2025, udi#: (b)(4) 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.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
B5; additional information received: the physician did not provide an exact cause for the limb occlusion although it was stated it may have been due to size of aortic bifurcation.The occlusion was only in the etlw1616c124e limb on the left side.No cause for the type ia endoleak was confirmed per the physician.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.

• Brand Name: ENDURANT II AORTIC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 18332024
• Report Number: 9612164-2023-05982
• Device Sequence Number: 6788116
• Product Code: MIH
• UDI-Device Identifier: 00613994991447
• UDI-Public: 00613994991447
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: 06/09/2024
• Device Model Number: ETCF2828C49E
• Device Catalogue Number: ETCF2828C49E
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/04/2024
• Date Device Manufactured: 06/10/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Male