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

Model Number VNMF3737C174TU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Ulcer (2274)

Event Date 10/02/2020

Event Type  Injury  

Event Description

Valiant navion stent grafts were implanted during endovascular treatment of a thoracic aortic dissection.It was reported approximately 3 years post the index procedure, follow up ct showed ascending aortic ulcer of the anterior proximal arch/ ascending aorta secondary to uncovered proximal stent.The patient required prolonged hospitalization.Approximately 3 weeks post admission the ulcer resolved without sequelae.The site assessed the aortic ulcer as having a probable relationship to the study device and procedure and not related to the dissection.The medical monitor assessed the aortic ulcer as related to the device and dissection and not related to the index procedure.No additional clinical sequalae were provided and the patient is fine.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: v nmc3731c207tu, serial/lot #: (b)(6), ubd: 20-aug-2022, 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
• Type of Device: 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: 18957945
• MDR Text Key: 338307698
• Report Number: 9612164-2024-01402
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000100681
• UDI-Public: 00763000100681
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: VNMF3737C174TU
• Device Catalogue Number: VNMF3737C174TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 03/22/2024
• Date Device Manufactured: 10/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H11...."
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 85 KG