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

Model Number	ETBF2313C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional concomitant medical product information references the main component of the system.Other relevant device(s) are: catalog number: etlw1613c124e, (b)(4), use by date 2017-02-03, (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Two endurant stent graft and heli-fx endoanchors were implanted in the patient for the endovascular treatment of an aortic abdominal aneurysm.Ct exam showed a maximum aneurysm diameter of 53mm.It was reported that 4 heli-fx endoanchors were implanted in the patient due to concern for late failure.It was noted that the patient had back pain and it was deemed to be causally related to the index procedure but not related to the device or aneurysm.The patient recovered with medication.It was reported that the patient expired.The cause of death was suicide and not aneurysm related.No additional clinical sequelae were reported.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7203374
• Report Number: 2953200-2018-00111
• Device Sequence Number: 16184185
• Product Code: MIH
• UDI-Device Identifier: 00613994991188
• UDI-Public: 00613994991188
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2018

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: 01/13/2017
• Device Model Number: ETBF2313C166E
• Device Catalogue Number: ETBF2313C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/18/2018
• 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: 63 YR
• Patient Weight: 86