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

Model Number	VNMC3131C90TU
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Pain (1994); Vomiting (2144); Rupture (2208); Vascular Dissection (3160)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant navion stent graft was implanted in the endovascular treatment of a thoracic aortic dissection.  it was reported that on the date of the event, the patient had awakened in the middle of the night with coughing and vomiting and experiencing excruciating abdominal pain that did not subside.The  patient presented to outside er and had ct scan which  showed a worsening distal thoracic and proximal abdominal aortic aneurysm with concern for contained rupture due to extensive pain.  five days later the patient was transferred to another facility for follow-up.The patient had a open thoracoabdominal repair of a further four days later as treatment.The patient required in patient or prolonged hospitisation.  the event resolved.The site assessed the aneurysm as not related to the study device, procedure or dissection under study.  the sponsor assessed it as related to the study device, not related to the study procedure and related to the dissection under study.  no additional clinical clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
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
Ct imaging reviewed by the site that was taken on the 5th of dec 22 have identified a type ia endoleak.The maximum aortic was 43mm.No migration was noted.Fenestrations proximal and distal to the endovascular graft with blood flow in the false lumen unchanged from prior.New descending aorta dissection 2.5 cm distal to distal end of endograft.Corelab reviewed and noted aortic enlargement along endograft +8.6mm (ongoing) and distal to the endograft +4.6mm (ongoing).No stent ring enlargement, fracture or endoleak were noted.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
Additional information received site review of contrast ct imaging from approximately 14 months after the index procedure showed presence of false lumen perfusion into the primary entry tear and a maximum aortic diameter of 43mm.No migration, new stent induced entry was observed and no extension of the dissection was noted were noted.Stent was patent.Fenestrations distal and proximal to graft with retrograde and antegrade flow into the false lumen were noted.Corelab review of ct imaging from the same date did not identify any endoleak, stent fracture or stent ring enlargement.Aortic enlargement of +6.5mm along the endograft and +5.3mm distal to the endograft 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: 16485975
• Report Number: 9612164-2023-01005
• Device Sequence Number: 20311316
• Product Code: MIH
• UDI-Device Identifier: 00763000260767
• UDI-Public: 00763000260767
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2022
• Device Model Number: VNMC3131C90TU
• Device Catalogue Number: VNMC3131C90TU
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 03/07/2023; 06/25/2024
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/30/2023; 07/01/2024
• Date Device Manufactured: 10/27/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: Black Or African American