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

Model Number	MCS-P3-26-AOA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Stenosis (2263)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the product remains implanted, therefore no product analysis can be performed.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 approximately three years and ten months following the implant of this transcatheter bioprosthetic valve, a non-medtronic valve was implanted valve-in-valve due to aortic stenosis caused by calcium buildup on the non-coronary cusp of the initial valve.It was reported that a deeper implant and the patient¿s existing medical issues at time of initial implant likely led to valve failure.No further 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: 7328468
• Report Number: 2025587-2018-00537
• Device Sequence Number: 10803039
• Product Code: NPT
• UDI-Device Identifier: 00643169430259
• UDI-Public: 00643169430259
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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: 12/26/2014
• Device Model Number: MCS-P3-26-AOA
• Device Catalogue Number: MCS-P3-26-AOA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/09/2018
• 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
• Patient Age: 56 YR