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

Model Number	VNMC2525C180TU
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: v nmc2525c94tu, serial/lot #: (b)(4), ubd: 21-aug-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Valiant navion stent grafts were implanted to repair an ivc on (b)(6) 2019.The navion stents were placed off label in the inferior vena cava.It was reported that on the (b)(6) 2019, the stent grafts were relined with a non mdt stent graft due to a collapsed stent.The cause of the stent collapse was not provided.No additional clinical sequelae were provided and the patient is fine.

• 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: 14433135
• Report Number: 9612164-2022-01875
• Device Sequence Number: 20273285
• Product Code: MIH
• UDI-Device Identifier: 00763000100940
• UDI-Public: 00763000100940
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2020
• Device Model Number: VNMC2525C180TU
• Device Catalogue Number: VNMC2525C180TU
• 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: 04/22/2022
• Initial Report FDA Received Date: 05/18/2022
• Date Device Manufactured: 09/11/2018
• 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: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female