MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT NAVION; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	VNMF3731C173TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/04/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: product id: vnmf3428c173tu, serial/lot #: (b)(4), ubd: 03-oct-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navion stent graft system was implanted in a patient for the emergent treatment of a ruptured thoracic aneurysm.Approximately two weeks later, the patient's wife called technical services to report that the patient did not survive the procedure.It was reported that during the index procedure, the patient's condition deteriorated and cpr was commenced.A rupture occurred before any of the devices were implanted and the patient expired post the procedure.As per the physician the cause of death was not device related.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8508278
• Report Number: 2953200-2019-00496
• Device Sequence Number: 1780651
• Product Code: MIH
• UDI-Device Identifier: 00763000100865
• UDI-Public: 00763000100865
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: 09/09/2020
• Device Model Number: VNMF3731C173TU
• Device Catalogue Number: VNMF3731C173TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/12/2019
• 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; Required Intervention
• Patient Age: 71 YR