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

Model Number FR995

Device Problems Structural Problem (2506); Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); Dyspnea (1816); No Information (3190)

Event Date 11/15/2016

Event Type  Injury  

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 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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6156550
• MDR Text Key: 61849136
• Report Number: 2025587-2016-01966
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169002098
• UDI-Public: 00643169002098
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2017
• Device Model Number: FR995
• Device Catalogue Number: FR995-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR