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	02/01/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: etlw1616c124e, sn (b)(4), expiration date: 2019-01-10, (b)(4).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.
Event or Problem Description
An endurant iis stent graft was implanted in the patient for endovascular treatment of a 70 mm max diameter ruptured abdominal aortic aneurysm.The proximal aortic neck diameter measured ~ 22-27 mm.There was minimal aortic neck angulation.The vessel was mildly calcified.It was reported the patient was fully coded before arriving to the operating room.A chest compression was done during the implant procedure.During the chest compression, the guidewire on the contralateral side punctured the artery and was subintimal.As a result, the physician was unable to cannulate the gate of the bifurcate.The patient received treatment.The physician implanted an endurant aui stent graft and an occluder; however, the event did not resolve and the patient expired.Per the physician, the cause of death was due to the pre-operative ruptured aneurysm and the amount of blood loss.No additional clinical sequelae were reported.
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: 6348080
• Report Number: 2953200-2017-00261
• Device Sequence Number: 13639284
• Product Code: MIH
• UDI-Device Identifier: 00643169232617
• UDI-Public: 00643169232617
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/01/2017

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: 05/25/2018
• Device Model Number: ETUF3214C102E
• Device Catalogue Number: ETUF3214C102E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 76 YR