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

Model Number FR995-29

Device Problems Perivalvular Leak (1457); Material Split, Cut or Torn (4008)

Patient Problems Foreign Body Reaction (1868); Valvular Insufficiency/ Regurgitation (4449)

Event Date 02/10/2021

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 9 years and 7 months post implant of this 29mm bioprosthetic aortic root replacement, it was explanted and replaced with an unknown device.The reason for the replacement was reported as "leakage around the aortic root due to inflammatory response which caused the root to erode and separate from the patient's native tissue".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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11327709
• MDR Text Key: 232327960
• Report Number: 2025587-2021-00539
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490816465
• UDI-Public: 00681490816465
• 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: 02/15/2021

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: 01/13/2016
• Device Model Number: FR995-29
• Device Catalogue Number: FR995-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 02/15/2021
• Date Device Manufactured: 02/02/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR