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

Model Number	ETLW1628C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Obstruction/Occlusion (2422)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 62mm abdominal aortic aneurysm.Bilateral common femoral artery aneurysms were noted (19rcfa &14lcfa).The left hypo was occluded.The right hypo was noted as narrow proximally (14mm) and aneurysmal distally.It was reported one month post the index procedure, follow up ct demonstrated a focal right iliac limb occlusion contained in etlw1 628c124e.Per the physician the cause of the occlusion is undetermined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received: it was confirmed that the occlusion was isolated to the limb, that the patient has suffered no adverse events and that future treatment has not been scheduled.Analysis summary: the reported right iliac limb occlusion could not be assessed on the films provided; therefore the cause of the event could not be d etermined.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy and post-implant ct¿s showing the occlusion were not provided.It is possible that the vessel/aneurysm thrombus observed may have been associated with an increased risk of occlusion of the iliac limb.Other possible contributors to vessel occlusion include an unknown coagulopathy that is now presenting or a previous history of pad leading to poor distal run-off.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 ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10815546
• Report Number: 9612164-2020-04337
• Device Sequence Number: 1901835
• Product Code: MIH
• UDI-Device Identifier: 00643169467453
• UDI-Public: 00643169467453
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 12/11/2020

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: 04/14/2022
• Device Model Number: ETLW1628C124E
• Device Catalogue Number: ETLW1628C124E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR