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

Model Number	VNMC3434C223TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/04/2018
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 system was implanted in a patient for an unknown thoracic endovascular treatment.The diameter of the proximal thoracic aorta was 37mm and the degree of angulation was 40 degrees.The patient also had a right sided arch with kommerell's diverticula.It was reported that during deployment, the first navion device was not delivered to its intended location and the device appeared to ride up towards the head, without actual movement of the device.The device was pulled back down to avoid coverage of the carotid.An additional valiant navion stent graft was implanted due to the difficulty experienced with the first device.It was noted there was no rapid right ventricular pacing maintained during deployment.Adenosine was used for procedural hypotension and to maintain forward pressure during deployment and the delivery system and guidewire were fully apposed to the greater curvature of the aorta during deployment.As per the physician, the cause of the event was due to the high angle of the aortic arch.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the reported stent graft inaccurate proximal placement could not be determined from the pre-implant films provided.Images during implant and post-implant ct¿s were not provided; therefore, the reported event could not be assessed.Pre-implant ct¿s returned confirmed that the patient had a right sided aortic arch, with dilation near the origin of the lsa; reported as a kommerell's diverticula.The dilated taa beginning ~20mm caudal from the rsa measured ~47mm in maximum diameter x 60mm in length.The angulation between the flow lumen near the rsa and the taa centerline was ~80 deg.It is possible that the highly angulated arch from this unusual anatomy may have contributed to the reported inaccurate proximal placement.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: 8179463
• Report Number: 2953200-2018-01700
• Device Sequence Number: 16476923
• Product Code: MIH
• UDI-Device Identifier: 00763000101039
• UDI-Public: 00763000101039
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 09/09/2020
• Device Model Number: VNMC3434C223TU
• Device Catalogue Number: VNMC3434C223TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/23/2019
• 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: 58 YR