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

Model Number	ETLW1624C199E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	12/26/2018
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, along with a chimney graft, for the endovascular treatment of an unknown size abdominal aortic aneurysm and dissection, as part of a pside study.It was reported a follow up ct carried out approximately five years later showed thrombus in the patient's etlw1624199e stent graft limb.The limb was relined with the stent graft limb etlw1624c156e to cover the thrombus and a reliant balloon was used to post-dilate the overlap.It was noted that the treatment was successful with no further issues.As per the physician, the cause of the event cannot be determined no additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported stent graft thrombus within the flared limb was confirmed; however, the exact cause of the thrombus could not be determined from the films provided.Review of pre-implant ct¿s revealed that the patient had bi-lobal aneurysms located within the descending and thoracoabdominal aorta.The descending thoracic contained thrombus and was essentially straight.Beginning near the level of the renal arteries the abdominal aorta was dissected, and the dissection continued down the entire length of the 43mm max diameter aaa, as well as into the left common iliac artery.Ct¿s returned from 57 months post-implant revealed that multiple stent grafts had been implanted in the patient¿s thoracic and thora co-abdominal aorta.Beginning at the bottom of the arch, the proximally placed valiant stent graft was seen extending ~6cm above and overlapping a ~5-piece endurant ii stent graft system.The left flared limb of the bifurcated system extended distally into the proximal portion of the infrarenal aaa, and organized thrombus was seen primarily within the distal portion of the left limb.No other appreciable thrombus was observed within or distal to the devices.The devices were essentially straight, with no stent graft kinks or compression seen, and no obvious endoleak was observed.Other than the moderate thrombus observed within the thoracic aorta prior to implant, analysis of the returned films did not reveal any anatomical characteristics that could explain the observed stent graft thrombus.This may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: 8266644
• Report Number: 2953200-2019-00135
• Device Sequence Number: 2370948
• Product Code: MIH
• UDI-Device Identifier: 00613994991713
• UDI-Public: 00613994991713
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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: 11/01/2014
• Device Model Number: ETLW1624C199E
• Device Catalogue Number: ETLW1624C199E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/26/2019
• 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: Required Intervention
• Patient Age: 73 YR