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

Model Number	VNMC3434C182TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Pain (1994)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navion stent graft was implanted in the endovascular treatment of a aortic dissection.It was reported that five days later, the patient arrived to the ed with acute abdominal pain and mild pain radiating to the back.Hypertension was also noted.A cta was performed which showed stable findings.The patient received medication for the hypertension.The patient was admitted for observation and then was discharged a day later with pain medication.A week later at follow-up the patient reported still some intermittent pain but overall felt improved and the event was deemed resolved.The site assessed the event unlikely related to the study device and possibly related to the procedure.The sponsor assessed it as not related to the study device and related to the procedure.No additional clinical sequelae were reported and the patient will be monitored.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 10885092
• Report Number: 9612164-2020-04554
• Device Sequence Number: 2882177
• Product Code: MIH
• UDI-Device Identifier: 00763000101022
• UDI-Public: 00763000101022
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: 04/02/2022
• Device Model Number: VNMC3434C182TU
• Device Catalogue Number: VNMC3434C182TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/23/2020
• 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: 51 YR
• Patient Weight: 77