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

Model Number FR995

Device Problems Material Rupture (1546); Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that 5 years 6 months post implant of this aortic bioprosthetic valve, the device had a leaflet tear and leaflet perforation.The physician excised the valve leaflets, left the body of the valve in place, and implanted a new valve inside of the existing device.No other adverse patient effects were reported.

• 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: 6772401
• MDR Text Key: 82003802
• Report Number: 2025587-2017-01329
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169008137
• UDI-Public: 00643169008137
• 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
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2016
• Device Model Number: FR995
• Device Catalogue Number: FR995-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2011
• 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: 60 YR