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

Model Number	VNMC4337C200TU
Medical Device Problem Codes	Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Insufficient Information (4580)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
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 the endovascular treatment of a 65mm thoracic aortic aneurysm.It was reported that during the index procedure, the device deployed without issue.During the removal of the delivery system, it got caught on the graft and pulled it back.No cause of the event was reported.No additional clinical sequelae were providedand the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary the reported dislodgement of the stent graft after difficulty to remove the delivery system was confirmed on the films provided; however the cause of the event could not be determined.Procedural angiogram showing the delivery system catching on the stent graft were not provided for full assessment of the cause of the difficult to remove event.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Stent graft oversizing may have been a consideration in the patient, with implantation of a 43mm stent graft in a vessel of 31mm diameter.It is likely that in the event of oversizing of a device, that infolding of the stent graft may occur, increasing the risk of a stent being caught on by the delivery system.Analysis of the returned films did not reveal any obvious anatomical anomalies that may have led to the reported difficulties in removing the delivery system.The delivery system was discarded and so a product investigation could not be performed.Additional information received; it was reported that the wire held the delivery system on the lateral curve and would not allow the delivery system to be pulled back.A balloon was used to dislodge the delivery system so that it could then be removed, it was reported the graft was pulled backed several centimeters and was crumpled.A second graft was placed a few days later with no issues.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: 10754365
• Report Number: 9612164-2020-04133
• Device Sequence Number: 1024509
• Product Code: MIH
• UDI-Device Identifier: 00763000101268
• UDI-Public: 00763000101268
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/02/2020

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: 08/11/2021
• Device Model Number: VNMC4337C200TU
• Device Catalogue Number: VNMC4337C200TU
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/11/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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: Required Intervention
• Patient Age: 71 YR