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

Model Number	ETUF3214C102E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Blood Loss (2597)
Date of Event	04/25/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: etlw1620c93e, sn (b)(4), expiration date: 2019-01-11, udi # (b)(4); etew2020c82e, sn (b)(4), expiration date: 2018-10-26, udi # (b)(4).
Event or Problem Description
An endurant ii aui stent graft system was implanted in a patient for the endovascular treatment of a 67 mm diameter abdominal aortic aneurysm.The aortic neck was 30 mm in length, 24 ¿ 27 mm in diameter from proximal to distal.The aortic bifurcation is 35 mm in diameter.The right iliac is 18 ¿ 33 mm in diameter from proximal to distal.The left iliac is 24 ¿ 17 ¿ 16 from proximal to distal.The right external iliac is 11 mm and the left is 7 mm.It was reported that there was no issues related to the stent graft; however, the patient had bleeding form the vena cava.The patient expired before leaving the or from bleeding complications from an adjunctive surgical procedure and ligation of the rcia.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Film evaluation summary: the cause of the vena cava bleeding complications occurring during an adjunctive surgical procedure and ligation of the rcia, could not be determined from the pre-implant films provided.Films during the implant were not available for review.Analysis of the returned films did not reveal any characteristics that could explain the reported event.Event unrelated to device per physician's documented assessment.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6579897
• Report Number: 2953200-2017-00821
• Device Sequence Number: 16402039
• Product Code: MIH
• UDI-Device Identifier: 00643169232617
• UDI-Public: 00643169232617
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 05/25/2017

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: 06/14/2017
• Device Model Number: ETUF3214C102E
• Device Catalogue Number: ETUF3214C102E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: Not provided; 05/25/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 06/06/2017; 10/03/2017
• 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: 82 YR
• Patient Weight: 80