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

Model Number	ETLW1620C93E
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	06/16/2018
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 the patient for the endovascular treatment of a 49mm abdominal aortic aneurysm.It was reported the patient presented emergently with thigh pain 3 days later.It was reported that a thrombectomy of the left stent graft was performed for the occlusion and then bilateral self-expanding stent were placed in the limbs at the level of the native aortic bifurcation.Subsequently, a compartment fasciotomy was performed.This resolved the event.As per the physician, the cause of the event can not be determined.No additional clinical sequalae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7673157
• Report Number: 2953200-2018-00993
• Device Sequence Number: 1474858
• Product Code: MIH
• UDI-Device Identifier: 00643169467514
• UDI-Public: 00643169467514
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2018

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: 02/02/2019
• Device Model Number: ETLW1620C93E
• Device Catalogue Number: ETLW1620C93E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/24/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/25/2018
• 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: 76 YR