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

Model Number	VNMF3737C59TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Two valiant navion stent grafts were implanted during  an unknown endovascular procedure.It was reported via corelab review of ct images dated (b)(6) 2020, (b)(6) 2020, (b)(6) 2021, (b)(6) 2021 and (b)(6) 2022 that a type ia endoleak was observed in vnmf3737c59tu ((b)(6)).It was noted that the type ia endoleak was new on (b)(6) 2020 and persistent on (b)(6) 2020, (b)(6) 2021, (b)(6) 2021 and (b)(6) 2022.There was no stent ring enlargement observed.Fracture and stent ring migration were non-evaluable due to device overlaps and calcium presence.The maximum aortic diameter was 219mm on (b)(6) 2020, 223mm on (b)(6) 2020, 244mm on (b)(6) 2021, 147mm on (b)(6) 2021 and 163mm on (b)(6) 2022.There was aortic enlargement of +25mm noticed on ct taken on (b)(6) 2021 compared to the ct from (b)(6) 2020.The cause of the event is undetermined.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: 17359766
• Report Number: 9612164-2023-03300
• Device Sequence Number: 12497991
• Product Code: MIH
• UDI-Device Identifier: 00763000100667
• UDI-Public: 00763000100667
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2023

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: 09/10/2020
• Device Model Number: VNMF3737C59TU
• Device Catalogue Number: VNMF3737C59TU
• 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: 06/27/2023
• Initial Report FDA Received Date: 07/20/2023
• Date Device Manufactured: 09/11/2018
• 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: 85 YR
• Patient Sex: Male