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

Model Number	VNMF4343C62TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10:this is a system report.The section d information is for the primary device, which was in use with the following: product id: vnmf4343c103tu, serial/lot #: (b)(6), ubd: 10-sep-2021, udi#: (b)(4); product id: vnmc3434c90tu, serial/lot #: (b)(6), ubd: 10-jul-2021, udi#: (b)(4).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
Three valiant navion stent grafts were implanted during an endovascular treatment of a taa.It was reported that ct taken at 40 months post index procedure demonstrated aortic enlargement.The aneurysm diameter measured 69 x 85mm compared to prior measurement of 69 x 69mm.Ct from 41 months pos-index procedure showed interval enlargement of the aneurysm sac; no discrete endoleak identified, raising concern for occult endoleak.Vascular notes from 42 months post-index stated that aortic enlargement occurred and the aneurysm diameter measured 89mm.A type i endoleak was suspected from the proximal neck due to tortuosity or from distal to previous tube graft only.Angio from one day earlier identified a type i endoleak along proximal right aspect of the graft; no evidence of type ii endoleak.43 months post-index multiple abdominal aortograms identified type i endoleak proximal end of graft, unable to determine if type ia or ib.Did not fully identify filling of the aneurysm sac.Did visualize lumbar and mesenteric branches appeared to back flow towards the aneurysm sac.44 months post-index contrast ct identified a fusiform infrarenal aaa measuring 8.6x2.5cm in cross section.No visible ¿active¿ endoleak.At this time the patient underwent a secondary procedure for the possible endoleak and/or aortic enlargement.Multiple aortograms did not visualize a type ia or type ib endoleak.No retrograde flow beyond the graft.Two valiant captivia stent grafts were implanted along with three endurant extension limbs.There were no reported complications of the secondary procedure.It was reported that 47 months post the index procedure ct imaging was performed which was reviewed by corelab.No endoleak or stent ring enlargement were noted.Any fracture or stent ring migrations were not examinable due to device overlaps and scan quality.New aortic enlargement of + 23.7mm was observed in comparison to a ct taken 11 months post the index procedure.The maximum aortic diameter measured 96.7mm.No cause was provided.No additional clinical sequalae 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: 20491928
• Report Number: 9612164-2024-04787
• Device Sequence Number: 3615237
• Product Code: MIH
• UDI-Device Identifier: 00763000100742
• UDI-Public: 00763000100742
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: 100040
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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: 09/25/2020
• Device Model Number: VNMF4343C62TU
• Device Catalogue Number: VNMF4343C62TU
• 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: 09/27/2024
• Initial Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 09/26/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Male