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

Model Number	ETLW1620C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348); Insufficient Information (4580)
Date of Event	08/02/2019
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 50 mm abdominal aortic aneurysm.It was reported that on follow up ct 5 years later, dilation of the distal right common iliac artery was noted with a type ib endoleak.As per the physician, the cause of the event is undetermined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Film evaluation summary: the reported distal type i endoleak within the right iliac was confirmed; however, the exact cause of the endoleak could not be determined from the returned films.The anatomy at implant is unknown, and earlier post-implant films were not provided for comparison.A likely distal type i endoleak was observed outside the flared right limb.It appears that continued disease progression via the reported iliac artery dilatation most likely contributed to the distal type i endoleak.The cause of the left limb occlusion could not be determined from the returned film report.It is possible that placement of the left limb into the angulated left common iliac, with a potential stent graft compression/kink and resulting flow restriction, may have led to the occlusion.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
On 02-dec-2021, additional information received: it was confirmed an unknown reintervention was completed in 2019.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 ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 8892638
• Report Number: 9612164-2019-03404
• Device Sequence Number: 18911652
• Product Code: MIH
• UDI-Device Identifier: 00613994991638
• UDI-Public: 00613994991638
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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,Followup
• Report Date (Section B): 12/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2015
• Device Model Number: ETLW1620C93E
• Device Catalogue Number: ETLW1620C93E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/02/2019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 08/14/2019; 12/02/2021
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/09/2019; 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2013
• 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: 67 YR
• Patient Sex: Male