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

Model Number FR995-27

Device Problems Degraded (1153); Stretched (1601); Material Perforation (2205)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/25/2013

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.(event date and explant date) are month/year valid only.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately 1 to 2 years post implant of this 27mm bioprosthetic aortic root valve, the valve was replaced.The surgeon reported that during re-operation, the sinotubular junction ( stj ) appear dilated.It was reported that the tissue was thin, and it appeared that the aortic root "lost its strength" and looked "liquidly" near the coronary buttons.Severe aortic insufficiency was present along with a perforation in an unspecified location of the valve.It was reported that there were no issues with the valve leaflets.Necrosis of the aortic wall was also reported.No additional 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: 10694827
• MDR Text Key: 211871356
• Report Number: 2025587-2020-03142
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2014
• Device Model Number: FR995-27
• Device Catalogue Number: FR995-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/18/2020
• Date Device Manufactured: 06/18/2009
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR