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

Model Number	VNMC4646C218TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	02/10/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: product id: vnmf4646c183tu, serial/lot #: (b)(4), ubd: 24-oct-2020, udi#: (b)(4); product id: vnmf4646c223tu, serial/lot #: (b)(4), ubd: 16-aug-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 endovascular treatment of a 370 mm thoracic aortic dissection.It was reported that two days post the index procedure the patient had a sudden cardiac arrest and died.The cause of the cardiac arrest is unknown.No additional clinical sequelae were reported and the patient has expired.

• 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: 8361601
• Report Number: 2953200-2019-00263
• Device Sequence Number: 19291023
• Product Code: MIH
• UDI-Device Identifier: 00763000101190
• UDI-Public: 00763000101190
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 01/01/2021
• Device Model Number: VNMC4646C218TU
• Device Catalogue Number: VNMC4646C218TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 02/22/2019
• 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
• Patient Age: 65 YR