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

Model Number	VNMC3434C182TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Intimal Dissection (1333); Occlusion (1984)
Date of Event	09/03/2020
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 grafts were implanted in a patient for the endovascular treatment of a 280 mm thoracic aortic dissection.It was reported that during the index procedure, the left common carotid artery (lcca) was covered by proximal tip capture stent of the navion covered seal device.The event was treated by implanting a v12 stent into lcca origin from the left brachial artery resulting in a brisk flow into the lcca.It was reported that the patient suffered a micro-cutdown of the left brachial artery that required to implant a lcca stent.As per the physician, cause of the event was that the physician repositioned the stent graft proximally after the full length had been deployed, before the tip capture had been released caused the fabric to recede back over the tip capture inner stent.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received: the event was reported to be due to the valiant device film evaluation summary: the reported inaccurate delivery of the device and subsequent partial vessel occlusion was observed on the films provided; however, the cause of the event was not fully determined.Lack of additional procedural angiograms or post-implant ct¿s did not allow for complete analysis of the stent graft in vivo positioning.It is possible that the proximal end of the graft and internal stents became caught on the capture fitting during tip capture release, leading to the unintended proximal displacement.It is also possible that there was forward pressure on the delivery system that was not sufficiently relieved prior to tip capture release.Analysis of the returned still angiograms did not reveal any obvious out of specification stent graft integrity issues.A device issue cannot be ruled out as a potential cause.However, the delivery system was discarded and a product investigation could not be performed.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.
Additional Manufacturer Narrative
Evaluation summary: one (1) photo of the proximal section of the graft was received.The graft material appears deformed and between two stents.One of the stents appears deformed.The inaccurate delivery could not be confirmed through review of the photo.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.

• 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: 10559670
• Report Number: 9612164-2020-03529
• Device Sequence Number: 3144292
• Product Code: MIH
• UDI-Device Identifier: 00763000101022
• UDI-Public: 00763000101022
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2020

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: 02/04/2021
• Device Model Number: VNMC3434C182TU
• Device Catalogue Number: VNMC3434C182TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/22/2020; 10/20/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/19/2020; 10/27/2020
• 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: 54 YR