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

Model Number	VNMC4040C55TU
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/10/2019
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 6 cm valiant navion cuff was implanted for the endovascular treatment of a thoracic pseudoaneurysm at the anastomosis site of a previous open repair.The navion cuff was deployed under rapid pacing.It was reported 3 weeks post the index procedure the patient returned for a follow up,cta identified that the pseudoaneurysm had not been excluded.To treat this event, the physician deployed a second navion cuff successfully.Per the physician, the cause of the event is that the device had ¿stacked¿ along the greater curvature and lost seal although that had not been identified in any way.It was noted that the first three proximal stents may have nested, resulting in displacement of the proximal fabric edge along the outer curve of the anatomy.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Fdc 24, off-label use - implanting within the ascending thoracic aorta film evaluation summary: lack of exclusion of the pseudoaneurysm located in the ascending thoracic at the anastomosis site of a previous open repair was confirmed post-implant; however, the exact cause could not be determined from the films returned.Per r & d analysis of the returned fluoro¿s and ct¿s, the device appeared to be in the approximate same position at the time of the secondary procedure, as compared to the index procedure.No clear root cause has currently been identified.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: 8435522
• Report Number: 2953200-2019-00382
• Device Sequence Number: 13902012
• Product Code: MIH
• UDI-Device Identifier: 00763000101084
• UDI-Public: 00763000101084
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (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): 08/22/2019

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: 10/07/2020
• Device Model Number: VNMC4040C55TU
• Device Catalogue Number: VNMC4040C55TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 07/30/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/16/2019; 08/22/2019
• 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: 61 YR
• Patient Weight: 62