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

Model Number	ETEW2424C82E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/06/2017
Type of Reportable Event	Death
Event or Problem Description
An endurant ii stent graft system was implanted in the patient for the treatment of an abdominal aortic aneurysm of unknown size.In the same procedure, a fem-fem bypass was performed for the treatment of occlusive disease of the iliac artery, using a 24mm endurant ii limb and a balloon mounted stent graft from another manufacturer.It was reported that post procedure, after further intervention, the patient expired.The cause of the event is undetermined.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Additional information received on this case reported that as per the physician, the cause of the death was attributed to the patient's poor anatomy, health and age.Date of death updated.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: 6960689
• Report Number: 2953200-2017-01595
• Device Sequence Number: 19219773
• Product Code: MIH
• UDI-Device Identifier: 00613994991409
• UDI-Public: 00613994991409
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: 03/23/2019
• Device Model Number: ETEW2424C82E
• Device Catalogue Number: ETEW2424C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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: Death
• Patient Age: 73 YR