MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	EVOLUTPRO-23-US
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	01/17/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device remains implanted, therefore no product analysis can be performed.Without return of the device, a conclusive cause cannot be determined.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
Medtronic received information that following the implant of this transcatheter bioprosthetic valve, valve-in-valve with a previously implanted non-medtronic surgical valve, the valve was constrained.The physician was concerned that a high gradient could result, so a post-implant balloon aortic valvuloplasty (bav) was performed with one inflation, for 30 seconds.The bav fractured the surgical valve, but no annular rupture or dissection occurred.The sick left ventricle did not recover after the rapid pacing of the bav.The patient coded for 20 minutes and resulted in death.It was reported that the patient died due to the bav pacing run.The cause of death was reported as sudden cardiac arrest, was related to the procedure and not related to the valve.No autopsy was performed.

• Brand Name: EVOLUT PRO TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7248567
• Report Number: 2025587-2018-00321
• Device Sequence Number: 110896
• Product Code: NPT
• UDI-Device Identifier: 00643169954434
• UDI-Public: 00643169954434
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• 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
• Report Date (Section B): 02/07/2018

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: 05/22/2019
• Device Model Number: EVOLUTPRO-23-US
• Device Catalogue Number: EVOLUTPRO-23-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/07/2018
• 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
• Patient Age: 70 YR