MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	FR995
Medical Device Problem Codes	Structural Problem (2506); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Regurgitation (1716); Dyspnea (1816); No Information (3190)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted and will not be available for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Additional information has been requested, but no new information has been received to date.
Event or Problem Description
Medtronic received information that approximately three years, three months post implant of this bioprosthetic aortic valve, this valve was replaced, valve-in-valve with a transcatheter bioprosthetic valve.No failure mechanism and no other adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that this device was replaced because of severe regurgitation, due to a possible leaflet tear.Prior to the replacement procedure, the patient presented with shortness of breath do this aortic valve insufficiency.No other adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6156550
• Report Number: 2025587-2016-01966
• Device Sequence Number: 18854495
• Product Code: LWR
• UDI-Device Identifier: 00643169002098
• UDI-Public: 00643169002098
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2016

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: 08/21/2017
• Device Model Number: FR995
• Device Catalogue Number: FR995-19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2016
• Supplement Date Received by Manufacturer: Not provided; 12/09/2016
• Initial Report FDA Received Date: 12/08/2016
• Supplement Report FDA Received Date: 12/13/2016; 09/27/2017
• 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: 67 YR