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

Model Number	VNMC3737C223TU
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); Thrombosis/Thrombus (4440)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: vnmc3737c182tu, serial/lot #: (b)(4), ubd: 08-jul-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Valiant navion stent grafts were implanted in the endovascular treatment of a thoracic aortic dissection.It was reported 3 days later, a clot was identified at the lij (left internal jugular) and extending to the brachiocephalic.The sponsor assessed the event as related to study device, procedure & dissection.It was reported that a residual dissection extension to the left common iliac artery was also diagnosed 3 days post the index procedure.The clinical events committee (cec) assessed this event as not related to the study device and related to the procedure.This event is continuing.No cause was reported.No additional clinical sequelae were provided and the patient will be monitored.
Additional Manufacturer Narrative
B5; additional information received : corelab review of non-contrast ct images from 3 days after the index procedure identified a stent graft infolding on device vnmc3737c182tu ( sn (b)(6)).The infolding was also noted on the same device on ct imaging at approximately 4 months , 18 months 24 months and 31 months post-index procedure.There was no endoleak and no fracture noted.Site review of the same images did not identify false lumen perfusion, endoleak, migration, or stent-induced new entry tear.The maximum aortic diameter at 3 days was noted to measure 63mm and at 24 months, 41mm.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
B5; additional information received : a ct was performed one year and one month post the index procedure.The site reviewed this and noted no false lumen perfusion, endoleak, sine or extension of dissection.The maximum aortic diameter measured 40mm.Corelab reviewed the same ct and noted no endoleak or fracture.Corelab noted the persistent stent graft infolding on the stent graft v29992395.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: 11795989
• Report Number: 9612164-2021-01816
• Device Sequence Number: 11755305
• Product Code: MIH
• UDI-Device Identifier: 00763000101077
• UDI-Public: 00763000101077
• 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
• 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): 08/14/2024

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: 03/10/2022
• Device Model Number: VNMC3737C223TU
• Device Catalogue Number: VNMC3737C223TU
• 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: 04/14/2021
• Supplement Date Received by Manufacturer: 03/14/2024; 08/09/2024
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 03/20/2024; 08/14/2024
• Date Device Manufactured: 03/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 113 KG