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

Model Number	VNMF4343C223TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: v nmc4343c175tu, serial/lot #: (b)(4), ubd: 20-aug-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a 55mm abdominal aortic aneurysm.A ct performed just over 7 years later revealed a type ia and type ii endoleak from lumbar arteries and a sac diameter of 65mm.During the same ct, it was found the patient had a new thoracic pau (penetrating atherosclerotic ulcer (pau).The physician decided to treat the pau 3 days later.Two valiant navion stent grafts were implanted as treatment.It was reported that shortly after this procedure, the patient suffered a cerebral vascular accident (cva) and was recovering in hospital.As per the physician, the cause of the cva was uncontrollable high blood pressure.The cause of the ia endoleak was anatomy and a hostile angled aortic neck with continued dilation of the aorta.No additional clinical sequelae were provided and the patient will be monitored.
Additional Manufacturer Narrative
B:5 additional information received; it was confirmed that the cva was considered to be procedural related during treatment of the pau and not associated with the endurant.It was noted that no intervention for the type ia endoleak is planned at this time.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 TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10828469
• Report Number: 9612164-2020-04393
• Device Sequence Number: 3024920
• Product Code: MIH
• UDI-Device Identifier: 00763000260569
• UDI-Public: 00763000260569
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 09/03/2022
• Device Model Number: VNMF4343C223TU
• Device Catalogue Number: VNMF4343C223TU
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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: Other; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 104