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

Model Number	VNMF2828C97TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A valiant navion stent graft was implanted during the endovascular treatment of a thoracic aneurysm.It was reported approximately 13 months post the index procedure, follow up ct identified a type ib endoleak located approximately 30mm above the celiac access.Intervention was completed where a non mdt stent graft was implanted in the distal descending thoracic aorta.Completion angiogram showed excellent sealing of the graft and a complete seal of the endoleak.It was reported approximately 2 years post the index procedure, the patient complained of pain at rest in the left lower extremity and pain with walking.Follow up determined the patient had an in-flow issue presumably from the patch closure.The physician elected to complete an angiogram with revascularization on this date.A 8x100mm self-expanding stent was placed up to the iliac bifurcation on the left.The patient status has been reported as doing well post this procedure.The cause of the type ib endoleak was not provided.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information: per the medical records received, the valiant navion stent graft was initially implanted to treat a penetrating aortic ulcer of the descending aorta measuring 27x9x16mm with pseudoaneurysm.The type ib endoleak was identified on follow up ct scan from approximately 1 year post index procedure.The intervention procedure was performed 3 days after the endoleak was observed.Per the physician's notes, it was probably or at least possible , but more like probable that the type ib endoleak was a result of graft defect.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
Film evaluation summary: the reported type ib endoleak and occlusion of the let iliac artery were confirmed ; however, the cause of the events could not be determined from the limited films and radiology reports available.The reports available did not include all of the images, and the available images were of low quality as the ct scan available had irregular intervals, except for the pre-implant and two post-implant 3d ct images it is possible that disease progression, including possible vessel dilatation may have contributed to the observed type ib endoleak, but this could not be confirmed.Analysis of the returned films did not reveal any obvious stent graft integrity issues.The observed bilateral calcific atherosclerosis, along with the presence of surgical clips noted in the left iliac artery, may have contributed to the occlusion, but this could also not be confirmed.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.

• 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: 16458177
• Report Number: 9612164-2023-00903
• Device Sequence Number: 12405244
• Product Code: MIH
• UDI-Device Identifier: 00763000100575
• UDI-Public: 00763000100575
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2023

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: 01/23/2021
• Device Model Number: VNMF2828C97TU
• Device Catalogue Number: VNMF2828C97TU
• Device Lot Number: V08217279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/31/2023; 06/23/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/13/2023; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown
• Patient Weight: 71 KG