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

Model Number	VNMF3434C229TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
A valiant navion stent graft was implanted in the endovascular treatment of type b aortic dissection.It was reported that when the patient returned for routine follow up a month later, a ct which was preformed six days previously showed the patient had a type a retrograde dissection.The patient was reported to be asymptomatic of the dissection.The patient was brought to or that day where the dissection was treated and resolved.As per the physician the cause of the event can not be determined.No additional clinical sequelae were provided and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported type a dissection was confirmed; however, the exact cause could not be determined from the returned films.Pre-implant ct¿s were not available for review, and the patient¿s anatomy including the type b dissection could not be assessed.Images during implant were not provided, and it is unknown if the stent graft excluded the type b across the arch at implant.Ct¿s from 1 month post-implant showed perfusion of the type b false lumen beginning across the arch, as well as a retrograde type a dissection beginning near the valiant proximal bare spring extending to just above the aortic valve.Analysis of the returned films did not reveal any stent graft characteristics that could explain the observed type a dissection.No stent graft integrity issues were observed.It is unclear if the patient¿s previous type b dissection may have been a contributor.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 type b aortic dissection on the (b)(6) 2019.It was reported that when the patient returned for routine follow up on the (b)(6) 2019, a ct which was preformed six days earlier on the (b)(6) 2019 showed the patient had a type a retrograde dissection.The patient was reported to be asymptomatic of the dissection.The patient was brought to or that day where the dissection was treated and resolved.

• 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: 9607052
• Report Number: 9612164-2020-00337
• Device Sequence Number: 2677344
• Product Code: MIH
• UDI-Device Identifier: 00763000100650
• UDI-Public: 00763000100650
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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: 01/23/2021
• Device Model Number: VNMF3434C229TU
• Device Catalogue Number: VNMF3434C229TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 02/24/2020
• 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: 55 YR