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

Model Number	VNMC3731C207TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/25/2019
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 the endovascular treatment of a 60 mm diameter thoracic aortic aneurysm.The diameter of the proximal thoracic aorta was 31 mm, there was moderate angulation of the thoracic arch, and the thoracic and abdominal aorta were moderately tortuous.No calcification was present in the thoracic aorta.It was reported that during the index procedure, when the physician was deploying the tip capture, the stent graft moved 20 mm distally from the intended landing zone.An additional valiant navion stent graft (vnmc3737c90tu) was implanted to cover the missed landing zone, and the procedure was completed.It was reported that the delivery system and guidewire were fully opposed to the outer curve of the aorta.Rapid pacing was not used.As per the physician, the cause of the event was related to the blood pressure pushing the device back.No additional clinical sequelae were reported, and the patient is fine.

• 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: 8522013
• Report Number: 9612164-2019-01368
• Device Sequence Number: 1885048
• Product Code: MIH
• UDI-Device Identifier: 00763000101244
• UDI-Public: 00763000101244
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 04/17/2019

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: 01/14/2021
• Device Model Number: VNMC3731C207TU
• Device Catalogue Number: VNMC3731C207TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/17/2019
• 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: 80 YR
• Patient Weight: 70