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

Model Number	VNMF4646C223TU
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); Aneurysm expansion (4597)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Two valiant navion stent grafts were implanted during an unknown endovascular procedure.It was reported approx.5 years, 11 months post index procedure, a secondary procedure was performed.This involved debranching of the left subclavian and vertebral artery with transposition.The patient experienced an estimated blood loss of 500cc but remained stable and did not require transfusion.Good flow was achieved in the subclavian, carotid and left vertebral arteries following the transposition.Two days later, a follow up procedure was conducted address proximal degeneration / graft migration which had resulted in a type ia endoleak.A proximal extension was placed as part of an endovascular aortic repair.Additional distal components were placed to treat expanding para visceral and distal descending of taa, which developed above the previously placed abdominal fenestrated graft.The superficial femoral artery (sfa) was noted to be diffusely diseased with two regions of severe stenosis.During this procedure, three non-medtronic grafts were successfully implanted in the thoracic aorta, achieving excellent flow through the grafts and effective coverage of the diseased aorta.The proximal type ia endoleak was resolved.The patient developed a pulse in left foot so the procedure so terminated.The inner cannula was removed, and hemostasis was achieved via pressure at the sfa access site.The patient was transferred to the pacu in stable condition.It was reported that corelab reviewed a ct from approx.6 years post index procedure and identified a new stent ring enlargement of +3.0mm on ring 4 of (b)(6) and +1.8mm on ring 3 of (b)(6).No endoleak, fractures or stent ring migration were noted.The maximum aortic diameter measured 67.3mm.No cause was provided.No additional clinical sequalae were provided and the patient will be monitored.
Additional Manufacturer Narrative
B5: additional information received; there are no plans for intervention to address the sre.The secondary procedure performed 5 years; 11 months post index procedure was performed in preparation for the procedure 2 days later.Specifically, the patient underwent debranching of the left subclavian and vertebral artery with transposition, and two days later the procedure involved the placement of a proximal extension.Therefore, these are part of the same event.Correction to event description: it was reported that corelab reviewed a ct imaging from approx.6 years post index procedure identified no aortic enlargement.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
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: 22227031
• Report Number: 9612164-2025-02979
• Device Sequence Number: 15542777
• Product Code: MIH
• UDI-Device Identifier: 00763000100810
• UDI-Public: (01)00763000100810(17)200816(21)V08088363
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Study,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2025

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: 08/16/2020
• Device Model Number: VNMF4646C223TU
• Device Catalogue Number: VNMF4646C223TU
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 07/31/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/04/2025; 07/31/2025
• Date Device Manufactured: 08/17/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005364322-02-19-2021-00
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 72 KG