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

Model Number FR995-29

Device Problems Material Separation (1562); Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); Dyspnea (1816); Fatigue (1849); Hematoma (1884); Pseudoaneurysm (2605); No Information (3190)

Event Date 10/28/2019

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 approximately 10 years post implant of this 29mm aortic bioprosthetic valve, the valve was explanted and replaced with a 25mm valve of the same model.The reason for the explant was not reported. no additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the reason for replacement was shortness of breath and fatigue along with a "vibration in his chest" which turned out to be a heart murmur.An echocardiogram was performed which showed severe left atrium enlargement.A transesophageal echocardiogram (tee) was performed which showed pseudoaneurysm and a peri-aortic mass extending to the right atrium.Upon opening the patients chest it was noted there was an extensive hematoma between the aorta and the main pulmonary artery measuring 18mm in size.There was evidence of a dense material around the aortic valve prosthesis, along with mild regurgitation.While removing the previous aortic root, it was noted that distal suture line had become separated at some point in the past.The replacement aortic bioprosthetic valve was successfully implanted.No additional adverse patient effects were reported.  added patient weight to weight updated patient and device code to adverse event problem added relevant history 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 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: 9395750
• MDR Text Key: 168637156
• Report Number: 2025587-2019-03635
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490816465
• UDI-Public: 00681490816465
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2014
• Device Model Number: FR995-29
• Device Catalogue Number: FR995-29
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 43