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

Model Number	ETLW1616C124E
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	06/25/2018
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 stent graft system was implanted in the patient for the endovascular treatment of a 65 mm abdominal aortic aneurysm.It was reported that approximately 4 years and 4 months post index procedure, a ct showed the patient had a type ib endoleak in the left limb due to the graft limb no longer engaging with the left common iliac artery.The cause of the event is unknown.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Intervention was completed where an endurant limb was implanted to resolve the type ib endoleak.Per the physician the cause was suspected to be related to disease progression.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: 7689438
• Report Number: 2953200-2018-01024
• Device Sequence Number: 756926
• Product Code: MIH
• UDI-Device Identifier: 00613994991591
• UDI-Public: 00613994991591
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2016
• Device Model Number: ETLW1616C124E
• Device Catalogue Number: ETLW1616C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/09/2018; 08/08/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 09/03/2018; 10/03/2018
• 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: 73 YR