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

Model Number	VNMF3434C174TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/28/2020
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 graft system was implanted for the endovascular treatment of a thoracic aneurysm.It was reported approximately 1 year post the index procedure, follow up ct identified a type ia endoleak.The physician performed a carotid to subclavian bypass and extended the graft to the origin of the left carotid.An additional valiant stent graft (vnmf3434c97tu v08246247) was implanted and the endoleak was confirmed as resolved.Per the physician the cause of the type ia endoleak was due to disease progression.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary the reported endoleak could not be confirmed on the films provided; therefore the cause of the event could not be determined.The anatomy at implant is unknown and post-implant films or procedural angiograms were not provided for review of the reported endoleak.Analysis of the returned report did not reveal any out of specification stent graft integrity issues.It is possible that the acutely angulated aortic arch or disease progression with aneurysm enlargement over 18 months post-implant may have been a factor in the occurrence of the type ia endoleak.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: 10717950
• Report Number: 9612164-2020-04059
• Device Sequence Number: 16973578
• Product Code: MIH
• UDI-Device Identifier: 00763000100643
• UDI-Public: 00763000100643
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/25/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2020
• Device Model Number: VNMF3434C174TU
• Device Catalogue Number: VNMF3434C174TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/25/2020
• 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: 63 YR