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

Model Number	VNMF2822C173TU
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/23/2018
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 was implanted in a patient for the endovascular treatment of thoracic aorta clots.It was reported that during the index procedure, the navion device was deployed, however the nose cone and delivery system were pulled down and caught on the distal end of the stent graft.During removal of the delivery system, the stent graft was pulled down from the thoracic aorta to the abdominal aorta.The stent graft was explanted and the event was resolved.The physician stated that the cause of the event was user error.It was reported that the recapture of tip to sheath was not performed under fluoroscopy.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received: the sequence of removal of the delivery device was: the trigger was pulled bringing the front grip towards the slider handle.The tip capture release handle was pushed forward to rotate to lock and the delivery system removed.It is noted that not removing under fluoroscopy is against the ifu together with implanting the device for the treatment of thoracic aorta clots.Off label for not removing delivery device under fluoroscopy together with implanting the device for the treatment of thoracic aorta clots.If information is provided in the future, a supplemental report will be issued.
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.

• 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: 8239192
• Report Number: 2953200-2019-00083
• Device Sequence Number: 16714409
• Product Code: MIH
• UDI-Device Identifier: 00763000100834
• UDI-Public: 00763000100834
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2019

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: 09/26/2020
• Device Model Number: VNMF2822C173TU
• Device Catalogue Number: VNMF2822C173TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2018
• Supplement Date Received by Manufacturer: 01/15/2019; 03/27/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 01/17/2019; 04/03/2019
• 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: 42 YR