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

Model Number FR995

Device Problem Material Rupture (1546)

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

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: since the valve has been implanted for over 10 years, it¿s very unlikely that the torn leaflet is due to any potential manufacturing issue.Without the return of the valve for analysis, a root cause of the torn leaflet cannot be determined.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 10 years 11 months post implant of this aortic bioprosthetic valve, the device was explanted and replaced due to a tear of the right leaflet at the coronary cusp.Additionally, mitral and tricuspid valve repairs were performed during the procedure.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: 6768122
• MDR Text Key: 81848001
• Report Number: 2025587-2017-01306
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490265904
• UDI-Public: 00681490265904
• 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: Health Professional
• Type of Report: Initial
• Report Date: 07/12/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2011
• Device Model Number: FR995
• Device Catalogue Number: FR995-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2006
• 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
• Patient Weight: 113