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

Model Number	VNMC4337C200TU
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
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 the endovascular treatment of a thoracic aortic dissection as part of the dissect-n study.It was reported that a follow-up ct taken 11 months later showed the maximum aortic diameter of 44mm.Corelab review of ct images dated (b)(6) 2022 showed aortic enlargement of +8.6mm proximal to the endograft.It was noted that there was no stent ring enlargement and no fracture seen on the ct and the imaging was non-evaluable for endoleaks.Site review of ct scan 17 months later identified a type iia endoleak.A ct scan 3 years and 2 months post the index procedure showed aneurysmal dilation of ascending aorta dilated *not within stent graft*.Up to 7x6.7cm compared to prior (6.4x6.3cm) ct imaging was performed 3 years and 5 months post the index procedure was reviewed by corelab.A new type iiib endoleak was identified on (b)(6).A new fracture on ring 4 was noted on (b)(6).New stent ring enlargement of + 3.6mm on ring 4, + 2.1mm on ring 5 and + 2.3mm on ring 6 on stent graft (b)(6) was also observed.No stent ring migration was noted.The maximum aortic diameter measured 69.9mm the cause of the 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.

• 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: 20006268
• Report Number: 9612164-2024-03745
• Device Sequence Number: 17234069
• Product Code: MIH
• UDI-Device Identifier: 00763000101268
• UDI-Public: 00763000101268
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: VNMC4337C200TU
• Device Catalogue Number: VNMC4337C200TU
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/20/2024
• Date Device Manufactured: 08/29/2019
• 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
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: White