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

Model Number 995

Device Problem Calcified (1077)

Patient Problems Calcium Deposits/Calcification (1758); Endocarditis (1834); Foreign Body Reaction (1868); Hemolysis (1886); Pulmonary Valve Stenosis (2024); Rupture (2208); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449)

Event Date 10/05/2021

Event Type  Injury  

Manufacturer Narrative

End date of survey results used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through a post market clinical follow-up survey on the freestyle bioprosthesis.Adverse events that were stated as related to a pre-existing patient condition: valve calcification, pannus, suture and paravalvular regurgitation.Adverse events that were stated as related to the procedure but not directly to the device: valve calcification, in tracuspal hematoma, hemolysis, pseudo-aneurysm, pannus, external compression, conduit kinking, leaflet rupture, stenosis, valve thrombosis, endocarditis and major paravalvular regurgitation.No unique device identifier numbers were provided.No additional adverse patient effects or product performance issues were reported.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12773802
• MDR Text Key: 283427770
• Report Number: 2025587-2021-03376
• Device Sequence Number: 1
• Product Code: LWR
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• 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): Life Threatening; Required Intervention