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

Model Number	VNMC3434C182TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
A valiant navion was implanted in the endovascular treatment of a thoracic aortic dissection.  a ct performed two months later identified a ib endoleak.It was reported that a ct with and without contrast was performed over one year later.The site reviewed this imaging and no endoleak, migration or false lumen perfusion were noted.The maximum aortic diameter was 47mm.It was noted there is excellent flow into the visceral arteries as well as the bilateral femoral arteries.  corelab reviewed the ct and noted aortic enlargement distal to endograft +9.4mm.No endoleak , stent ring enlargement or fracture were noted.  a ct with and without contrast was performed on the 20th of jan 23.No endoleak, false lumen perfusion or migration were noted by the site.The maximum aortic diameter was noted as 46mm.Corelab reviewed the same imaging and noted aortic enlargement of +12.4mm distal to the endograft (ongoing).No endoleak , fracture or stent ring enlargement were noted.No additional clinical sequalae were provided and the patient will be monitored.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19719297
• Report Number: 9612164-2024-03202
• Device Sequence Number: 20914933
• Product Code: MIH
• UDI-Device Identifier: 00763000260811
• UDI-Public: 00763000260811
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2022
• Device Model Number: VNMC3434C182TU
• Device Catalogue Number: VNMC3434C182TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 07/11/2024
• Date Device Manufactured: 11/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 77 KG