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

Model Number	VNMC2828C90TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Valiant navion stent grafts were implanted during the endovascular treatment of an taa.The patient had 4 existing valiant captivia grafts implanted 6 years previous.It was reported core lab review of ct imaging from approximately 3 years post the navion implant, showed a ib endoleak on vnmc2828c90tu ((b)(6)).No stent fracture, stent ring enlargement or stent ring migration was observed.The maximum aortic diameter was noted as 59.5mm.Device order on imaging was not confirmed.A non navion type ia endoleak was observed proximally.The cause of the endoeaks are undetermined.No additional clinical sequalae were provided and the patient will be monitored.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: v amf3636c150tu, serial/lot #: (b)(6), ubd: 03-oct-2015, udi#: (b)(4); product id: vamf4040c150tu, serial/lot #: (b)(6), ubd: 15-aug-2015, udi#: (b)(4); product id: vamc3834c150tu, serial/lot #: (b)(6), ubd: 19-apr-2015, udi#: (b)(4).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.

• 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: 19615579
• Report Number: 9612164-2024-03009
• Device Sequence Number: 12499731
• Product Code: MIH
• UDI-Device Identifier: 00763000100957
• UDI-Public: 00763000100957
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 06/26/2024

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: 02/19/2021
• Device Model Number: VNMC2828C90TU
• Device Catalogue Number: VNMC2828C90TU
• 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: 06/21/2024
• Initial Report FDA Received Date: 06/26/2024
• Date Device Manufactured: 02/20/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 93 KG