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

Model Number	VNMC4646C175TU
Medical Device Problem Codes	Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/26/2019
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 a patient for the endovascular treatment of a 60mm diameter thoracic aortic aneurysm.It was reported that during the index procedure, while deploying a second device, a valiant navion, in the descending thoracic aorta the mean arterial pressure (map) was allowed to increase from 60 to 92 by the anesthetist for the patient.Due to this change, the physician noted the device starting to be pushed back when approximately 2/3rd of the stent graft was deployed.This led to the device almost infolding on itself and the proximal end was 80-100mm below target.It was requested that the map be lowered and the physician was able to push up the un-deployed distal end of the device above the target and finish deployment.The delivery system was successfully removed and another navion stent graft was deployed through the "accordion" part of the previous navion device to bridge the devices together.This was successful and the case was completed with the patient doing well.As per the physician, the cause of the event was related to the combination of the high map and the use of the largest thoracic device.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received: the vessel had moderate tortuosity and little plaque.Ventricular pacing was not used during deployment.Forward pressure was maintained, and the delivery system and guidewire were fully opposed to the greater curve of the aorta during deployment.The physician believed the device acted differently than expected during the attempted positioning.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: 8373457
• Report Number: 2953200-2019-00282
• Device Sequence Number: 2120685
• Product Code: MIH
• UDI-Device Identifier: 00763000101183
• UDI-Public: 00763000101183
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: 12/19/2020
• Device Model Number: VNMC4646C175TU
• Device Catalogue Number: VNMC4646C175TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/19/2019
• 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: 76 YR