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

Model Number	VNMC3131C90TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pseudoaneurysm (2605)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navion stent graft system was implanted in an unknown endovascular procedure.It was reported that approximately 21 months post index procedure, the patient returned for a follow-up where a distal pseudoaneurysm with a possible infection was observed.The event was treated on the next day with a 32x28x150 valiant captivia implanted.No cause of the event was reported.No additional clinical sequalae were provided and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received: it was reported that the patient had positive blood cultures and the physician believes the issue was caused by an infection.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 system was implanted in an unknown endovascular procedure on the (b)(6) 2019.It was reported that on the (b)(6) 2021, the patient returned for a follow-up where a distal pseudoaneurysm with a possible infection was observed.The event was treated on the next day with a 32x28x150 valiant captivia implanted.No cause of the event was reported.No additional clinical sequalae were provided and the patient will be monitored.
Additional Manufacturer Narrative
Product analysis the reported infection could not be confirmed on the films provided; therefore the cause of the event could not be determined.The reported tissue changes in the distal stent graft area were confirmed and appeared to be pseudo aneurysmal in nature.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy or the original transection.It is unknown if the patient had co-morbidities that may have contributed to the reported infection.Analysis of the returned ct¿s did not reveal any obvious out of specification stent graft integrity issues.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
• MDR Report Key: 12233078
• Report Number: 9612164-2021-02889
• Device Sequence Number: 3970721
• Product Code: MIH
• UDI-Device Identifier: 00763000100971
• UDI-Public: 00763000100971
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2021

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: 10/24/2020
• Device Model Number: VNMC3131C90TU
• Device Catalogue Number: VNMC3131C90TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/04/2021; 10/05/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/01/2021; 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR