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

Model Number VNMF3131C229TE

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

Patient Problems Aneurysm (1708); Vascular Dissection (3160)

Event Date 12/15/2020

Event Type  Injury  

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 Description

A valiant navion stent graft was implanted during the endovascular treatment of a thoracic aortic dissection.It was reported approximately 4 years post the index procedure, follow up ct with and without contrast performed by the site showed a slight growth of aortic diameter behind stent graft.The maximum aortic diameter was noted to measure 54mm.No endoleak, false lumen perfusion, migration were reported.A stent induced new entry tear was identified.Corelab review of the cts from the same date noted aortic enlargement of +6.2mm ¿ along endograft.Corelab review did not identify any endoleak, stent ring enlargement or fracture.No additional clinical sequelae were provided and the patient will be monitored.

• 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: 19058883
• MDR Text Key: 339579668
• Report Number: 9612164-2024-01647
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2024

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: 10/29/2021
• Device Model Number: VNMF3131C229TE
• Device Catalogue Number: VNMF3131C229TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/08/2024
• Date Device Manufactured: 10/30/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 70 KG