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

Model Number FR995-27

Device Problem Insufficient Information (3190)

Patient Problem Vascular Dissection (3160)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that immediately post implant of this 27mm aortic bioprosthetic valve in a patient with a native bicuspid aortic valve, the surgeon noted bleeding from the graft.It was identified that the muscular tissue had "dislodged and dissected" from the cuff between the right and non-coronary.During the initial implant, the surgeon created buttons, cut out the native leaflets and made a felt gasket.The valve was ultimately explanted after the bleeding was identified, and was replaced with a non-medtronic valve, which extended the procedure an additional hour.No additional 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
• MDR Report Key: 8518854
• MDR Text Key: 142086679
• Report Number: 2025587-2019-01220
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169008137
• UDI-Public: 00643169008137
• Combination Product (y/n): N
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

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: 04/03/2023
• Device Model Number: FR995-27
• Device Catalogue Number: FR995-27
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 120