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

Model Number	ENBF3616C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Confusion/ Disorientation (2553)
Date of Event	05/06/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: enlw1620c124e, serial/lot #: (b)(4), ubd: 01-dec-2013, udi#: (b)(4); product id: enlw1616c82e, serial/lot #: (b)(4), ubd: 05-feb-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx guide, applier and endoanchors were used prophylactically in the endovascular treatment of the patient.An endurant stent graft system was also implanted on the same date.It was reported 2 days post the index procedure that the patient had an altered mental status that was noted to be related to the index procedure.The had a prolonged hospitalization and the event resolved with treatment 8 days post the index procedure.No additional clinical sequelae were reported and patient will be monitored.

• Brand Name: ENDURANT 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: 7556609
• Report Number: 2953200-2018-00795
• Device Sequence Number: 19441813
• Product Code: MIH
• UDI-Device Identifier: 00613994762375
• UDI-Public: 00613994762375
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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: 10/25/2013
• Device Model Number: ENBF3616C166E
• Device Catalogue Number: ENBF3616C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/31/2018
• 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: Hospitalization; Required Intervention
• Patient Weight: 60