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

Model Number	VNMC3737C223TU
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: v nmc4343c175tu, serial/lot #: (b)(4), ubd: 09-oct-2020, 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  250mm thoracic aortic dissection.It was reported approximately 1 year post the index procedure possible stent fracture/enlargement was observed on follow up ct.  no cause was reported.  no additional clinical sequalae were provided and the patient will be monitored.
Additional Manufacturer Narrative
The core lab reviewed images and and have determined that the diameters do not indicate a stent ring enlargement.It was observed that the true lumen is somewhat ¿flat¿ and it is preventing the device from fully expanding.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: 12568120
• Report Number: 9612164-2021-03799
• Device Sequence Number: 1100492
• 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: 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): 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2022
• Device Model Number: VNMC3737C223TU
• Device Catalogue Number: VNMC3737C223TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Patient Age: 55 YR