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

Model Number	VNMC3434C52TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Insufficient Information (4580)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant navion stent graft (vnmc3434c52tu) was implanted during the endovascular treatment of a thoracic aortic aneurysm.The patient had two existing aneurx and a talent abdominal stent grafts implanted approximately 11 years prior, and an additional talent stent graft implanted approximately 10 years prior to the implantation of the valiant navion.It was reported that since the implant of the valiant navion, the patient had presented to ed with uti and post post-op pain.It was reported ct imaging taken 3years and 2 months after the valiant navion procedure, revealed post-operative changes from tevar and aortoiliac stent graft placement.The maximum thoracic aortic diameter measured 59mm, unchanged from previous measurements, with no observed endoleaks.The maximum juxta-renal aortic aneurysm diameter was approximately 53mm, consistent with prior measurements.Intervention occurred 12 days later , involving tevar, relining of renal artery stents, and splenic artery embolization.It was noted on an unknown date, interval increase in size of the juxta renal aortic aneurysm measuring 55mm along with postsurgical changes of the open descending thoracoabdominal aortic aneurysm repair, thoracic endovascular aorta repair and kissing biliac stents.Unchanged size of the excluded aneurysm sac in the chest.No endoleaks present.3 month after the intervention involving tevar and relining of the renal artery stents and splenic artery embolization, the patient underwent splenic artery embolization and hepatic artery stenting via a left brachial artery approach.Additional reinvention for prior aortic repair took place 4 months later, involving fevar, cutdown of bilateral femoral vessels with patch angioplasty, and left axillary artery cutdown.The cause of the adverse event is undetermined.No additional clinical sequalae were provided and the patient will be monitored.
Additional 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.
Additional Manufacturer Narrative
Correction to b1.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
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 19319651
• Report Number: 9612164-2024-02323
• Device Sequence Number: 7659124
• Product Code: MIH
• UDI-Device Identifier: 00763000101008
• UDI-Public: 00763000101008
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 05/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2021
• Device Model Number: VNMC3434C52TU
• Device Catalogue Number: VNMC3434C52TU
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 05/15/2024
• Date Device Manufactured: 10/21/2019
• 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: 88 YR
• Patient Sex: Male