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

Model Number	VNMF4343C103TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2021
Type of Reportable Event	Death
Event or Problem Description
Valiant navions stent graft were implanted during the endovascular treatment of a thoracic aneurysm.  it was reported that on ct performed approximately 9 months post the index procedure an aortic stent graft was identified extending from the aortic arch to the distal descending thoracic aorta.Contrast was identified in the aneurysmal sac outside of the stent graft, consistent with an endoleak.The size of the aneurysmal sac of the descending thoracic aorta was relatively stable, measuring 84mm in maximum diameter.The endoleak is new compared with prior exam.  there was no  cause of endoleak provided.  the patient has died on an unknown date due to an unknown cause.No additional clinical sequelae was reported and the patient has expired.
Additional Manufacturer Narrative
Concomitant medical products: information references the main component of the system.Other relevant device(s) are: product id: vnmc4337c200tu, serial/lot #: (b)(4), ubd: 15-oct-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Continued from h9 3005364322-02-19-2021-001-r.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Core lab review of ct imaging from approximately 3 days, 2 months and 4 months post index procedure observed no endoleak, stent ring enlargement or stent ring migration and were not evaluable for fracture.Core lab review of ct imaging from approximately 4 months post index procedure was not evaluable for endoleak, fracture or stent ring enlargement and no stent ring migration was observed.Core lab review of ct imaging from approximately 9 months post index procedure was not evaluable for endoleak or fracture and no stent ring enlargement or stent ring migration was observed.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: 15812835
• Report Number: 9612164-2022-04281
• Device Sequence Number: 5837975
• Product Code: MIH
• UDI-Device Identifier: 00763000100759
• UDI-Public: 00763000100759
• 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): 06/26/2024

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: 02/25/2021
• Device Model Number: VNMF4343C103TU
• Device Catalogue Number: VNMF4343C103TU
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 05/03/2023; 05/28/2024
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 05/04/2023; 06/26/2024
• Date Device Manufactured: 02/26/2019
• 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: SEE H10
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Outcome Attributed to Adverse Event: Death
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 64 KG