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

Model Number	VNMC3434C182TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/12/2019
Type of Reportable Event	Death
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 31 mm thoracic aortic dissection.The patient presented emergently, having an mi.A ct then showed that the patient had a type b dissection, with malperfusion to all visceral branches and the entire abdominal and iliacs were occluded/ thrombosed.The patient had 2 coronary stents placed prior to the tevar.It was reported that during the implant procedure, the navion was placed in the aortic arch, intentionally covering the subclavian artery and landing just distal to the left carotid.It was reported that the final angiogram looked good, with true lumen expansion.However when the physician was closing the groin incision, the patient's blood pressure dropped and cpr was performed.A tee was performed and no type a retrograde dissection was noted.After 40 minutes of cpr, the patient died.As per the physician, the cause of the event could not be determined.No additional clinical sequelae were reported.

• 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: 8716284
• Report Number: 9612164-2019-02455
• Device Sequence Number: 2212276
• Product Code: MIH
• UDI-Device Identifier: 00763000101022
• UDI-Public: 00763000101022
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/20/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: VNMC3434C182TU
• Device Catalogue Number: VNMC3434C182TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/20/2019
• 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: Death; Required Intervention
• Patient Age: 69 YR