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

Model Number	MCS-P3-26-AOA-US
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/29/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the product remains implanted therefore no product analysis can be completed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.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, severe paravalvular leak (pvl) was noted.Subsequently, a second valve was implanted.No additional adverse patient effects were reported.

• Brand Name: COREVALVE 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: 7865594
• Report Number: 2025587-2018-02392
• Device Sequence Number: 1703403
• Product Code: NPT
• UDI-Device Identifier: 00643169448537
• UDI-Public: 00643169448537
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

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: 11/10/2016
• Device Model Number: MCS-P3-26-AOA-US
• Device Catalogue Number: MCS-P3-26-AOA-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2015
• Initial Report FDA Received Date: 09/11/2018
• 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: Required Intervention