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

Model Number FR995-21

Device Problems Material Puncture/Hole (1504); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Cusp Tear (2656); No Information (3190)

Event Date 09/07/2018

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 approximately 14 years and 3 months post implant of this aortic bioprosthetic valve, the valve was explanted and replaced with another valve. the reason for the explant was not reported. no additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the aortic valve was replaced due to severe regurgitation and moderate-to-severe stenosis.Visual inspection of the valve prior to explant revealed a torn left coronary leaflet and subvalvular pannus.The valve was replaced with a non-medtronic bioprosthetic valve.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Patient code added/corrected.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.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 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
• MDR Report Key: 8236541
• MDR Text Key: 132780639
• Report Number: 2025587-2019-00142
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490265898
• UDI-Public: 00681490265898
• Combination Product (y/n): N
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2019

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 Model Number: FR995-21
• Device Catalogue Number: FR995-21
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2019
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 03/19/2019; 04/02/2019
• Supplement Dates FDA Received: 03/19/2019; 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR