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

Model Number 310C29

Device Problems Gradient Increase (1270); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Thrombus (2101)

Event Date 07/08/2019

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 7 months post implant of this 29mm bioprosthetic mitral valve, it was explanted and replaced with a 31mm non-medtronic bioprosthetic valve.The reasons for replacement were reported as severe stenosis with mild transvalvular regurgitation, pannus formation, and inflammation.It was also reported that the bioprosthetic valve appeared endothelialized with "organized thrombi on the undersurface of the leaflets".No additional adverse patient effects were reported.

Manufacturer Narrative

The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Review of the operative report and images submitted by the health care provider revealed no new information.Without the return of the valve for analysis, a root cause of the regurgitation, high gradients, stenosis, and clot could not be determined.B7: updated h6: coding updated.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: MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
• 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: 9770002
• MDR Text Key: 182004424
• Report Number: 2025587-2020-00627
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169594852
• UDI-Public: 00643169594852
• Combination Product (y/n): N
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2023
• Device Model Number: 310C29
• Device Catalogue Number: 310C29
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR