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

Model Number	VNMC4343C218TU
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: v nmc4337c200tu, serial/lot #: (b)(6), ubd: 24-mar-2022, 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
Valiant navion stent grafts were implanted in the endovascular treatment of a thoracic aortic dissection.It was reported on the 23 months later, a ct without contrast was performed.The site identified a ib endoleak.No false lumen perfusion or migration was noted.The maximum aortic diameter was 52mm.No stent graft induced new entry tear or dissection extension was noted.Corelab reviewed the same imaging, no endoleak or stent ring enlargement was noted.Ne for fracture and stent ring migration due to slice thickness.Aortic enlargement proximal to the endograft of +17.7mm was observed.A ib endoleak was noted on a ct with contrast dated nine months later.No cause was reported.No additional clinical sequalae were provided and the patient will be monitored.
Additional Manufacturer Narrative
B5: additional information received: ct imaging performed approximately 31 months post-index procedure was reviewed by the site and corelab.The site noted the ib endoleak.No migration, sine or any extension of dissection was observed.The maximum aortic diameter measured 36mm.It was noted there was stable findings, proximal stent migration with stable aortic diameter.Corelab's review of the same imaging noted no endoleak or fracture.A new stent ring enlargement of +1.6mm on ring 3 was noted along with new stent ring migration of +0.2mm on ring 7 was also observed.Site review of non contrast cts from approximately 39 months pst-index procedure identified migration.Image not assessable for endoleak.No sine or extension of dissection observed.The maximum aortic diameter measured 59mm.Corelab review of same images noted aortic enlargement of +22.5mm, persistent stent ring migration of +3.5mm, in stent ring 7 and persistent stent ring enlargement in +1.9mm in stent ring 3.No stent graft migration was observed.These findings were observed in device vnmc4343c218tu, sn (b)(6).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: 19719016
• Report Number: 9612164-2024-03200
• Device Sequence Number: 8327678
• Product Code: MIH
• UDI-Device Identifier: 00763000101152
• UDI-Public: 00763000101152
• Combination Product (Y/N): N
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2025

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: 03/02/2022
• Device Model Number: VNMC4343C218TU
• Device Catalogue Number: VNMC4343C218TU
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 01/10/2025
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 11/18/2024; 01/10/2025
• Date Device Manufactured: 03/02/2020
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White