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

Model Number FR99525

Device Problem Insufficient Information (3190)

Patient Problems Aortic Valve Stenosis (1717); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)

Event Date 04/12/2021

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 10 years and 7 months post implant of this bioprosthetic aortic root valve, it was explanted and replaced with a valve of the same size and model.The reason for the replacement was not reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that 10 years 7 months post implant of this 25mm bioprosthetic aortic root valve, it was explanted and replaced do to thrombosis of the non coronary cusp which had been present for approximately 3 years.Additionally there was mild aortic insufficiency and a pseudoaneurysm of the ascending aorta root extending beyond the distal suture line of the previous root replacement, which required resection.Approximately 8 years post implant the patient suffered a cerebral vascular accident (cva) which was documented by a computed tomography (ct) scan.Immediately post implant there was mild regurgitation which was completely resolved at discharge.The explanted valve was analyzed at the facilities pathology department and found that there was thrombus in one of the leaflet sinuses associated with clinically mild aortic regurgitation and mild stenosis.No additional adverse patient effects were reported.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11761812
• MDR Text Key: 248615023
• Report Number: 2025587-2021-01401
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: FR99525
• Device Catalogue Number: FR99525
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 118