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

Model Number VNMF4034C185TU

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2023

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 (vnmf4034c185tu) was implanted during the endovascular treatment of a thoracic aortic dissection. the patient had an existing valiant captivia (vamf4040c150tu) thoracic stent graft implanted 6 years previoulsy.It was reported core lab review of ct imaging taken approximately 4 years post the index procedure showed a type ia (new) endoleak.The max aortic diameter was noted as 89.1mm.The imaging was na for aortic enlargement.No stent fracture, stent ring enlargement or stent ring migration was observed. a reintervention was performed.The cause of the type ia endoleak is undetermined.  no additional clinical sequalae 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: 19141811
• MDR Text Key: 340561202
• Report Number: 9612164-2024-01888
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000100872
• UDI-Public: 00763000100872
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2020
• Device Model Number: VNMF4034C185TU
• Device Catalogue Number: VNMF4034C185TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Date Device Manufactured: 09/25/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 79 KG