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

Model Number FR99525

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); No Information (3190)

Event Date 05/23/2019

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 10 years and 10 months post implant of this bioprosthetic valve in the pulmonary position of a pediatric patient, a transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve.The reason for the intervention was not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that this bioprosthetic valve was replaced due to stenosis and moderate regurgitation.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

• Brand Name: FREESTYLE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8671926
• MDR Text Key: 147098000
• Report Number: 2025587-2019-01823
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 10681490265918
• UDI-Public: 10681490265918
• 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: 07/11/2019

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: 09/06/2012
• Device Model Number: FR99525
• Device Catalogue Number: FR99525
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 51