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

Model Number	VNMC3434C182TU
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navion stent graft system was implanted in an unknown size thoracic aortic dissection on the (b)(6) 2020.It was reported that a ct was performed during a 1 year follow-up, identified a type iib endoleak.The event is continuing.The investigator assessed the type iib endoleak as not related to index device or procedure, but probably related to the dissection.Sponsor assessed the type iib endoleak as not related to index device, but related to index procedure and the dissection.Cec adjudicated the type iib endoleak as related to index device and not related to index procedure.On (b)(6) 2022: it was reported that corelab review of ct imaging from the (b)(6) 2021 identified a stent-induced new entry tear.The maximum aortic diameter was noted to measure 56mm.No additional clinical sequalae were provided and the patient will be monitored.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navion stent graft system was implanted in an unknown size thoracic aortic dissection on the (b)(6) 2020.It was reported that a ct was performed during a 1 year follow-up, identified a type iib endoleak.The event is continuing.The investigator assessed the type iib endoleak as not related to index device or procedure, but probably related to the dissection.Sponsor assessed the type iib endoleak as not related to index device, but related to index procedure and the dissection.Cec adjudicated the type iib endoleak as related to index device and not related to index procedure.On (b)(6) 2022: it was reported that corelab review of ct imaging from the (b)(6) 2021 identified a stent-induced new entry tear.The maximum aortic diameter was noted to measure 56mm.No additional clinical sequelae 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: 13630869
• Report Number: 9612164-2022-00823
• Device Sequence Number: 20102693
• Product Code: MIH
• UDI-Device Identifier: 00763000101022
• UDI-Public: 00763000101022
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: VNMC3434C182TU
• Device Catalogue Number: VNMC3434C182TU
• 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: 02/18/2022
• Initial Report FDA Received Date: 03/01/2022
• Date Device Manufactured: 04/02/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 78 KG