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

Model Number 310CJ29

Device Problems Material Separation (1562); Incomplete Coaptation (2507); Material Deformation (2976)

Patient Problems Host-Tissue Reaction (1297); Mitral Regurgitation (1964); Mitral Valve Prolapse (2471)

Event Date 04/01/2020

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 post implant of this bioprosthetic mitral valve, it was explanted and replaced with a n on-medtronic bioprosthetic valve.It was reported that the p2 leaflet of the valve prolapsed, resulting in regurgitation.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed the sewing ring was damaged and appears to have been cauterized during the explant process, exposing the stent.The valves appears to be distorted in an oval shape.The right cusp appeared open, resting on the inner outflow rail.The left cusp and non-coronary cusp were in the closed position with left cusp being prolapsed resulting from the dehisced commissure.All leaflets were slightly stiff but flexible except where host tissue extends on the inflow and outflow.The left cusp appeared prolapsed due to the right/left commissure being dehisced, which was possibly due to separation of the layers of aortic wall behind the commissure.The sutures holding the aortic wall to the stent post were partially visible and appeared intact.The right/non-coronary and left/non-coronary commissures appeared intact.Remnants of tan pannus remained attached to the inflow base stitching and existing sewing ring.Tan pannus was noted on the non-coronary and right outflow rails.An unknown amount of pannus may have been removed during explant.Radiography did not reveal calcification on the returned valve.Conclusions: since the valve had been implanted for 10 years, it is highly unlikely that the regurgitation is due to any potential manufacturing issue.The regurgitation can be traced to the dehisced commissure causing the prolapsed leaflet.Pannus growth, which is often considered a patient-related condition, applied pressure to the device, resulting in detachment of the aortic wall from the commissure.Based on the risk analysis and historical trend, cuspal tear and/or commissure dehiscence were the most common mechanisms which could lead to regurgitation.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: 9948336
• MDR Text Key: 187211160
• Report Number: 2025587-2020-01213
• Device Sequence Number: 1
• Product Code: LWR
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

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: 09/17/2014
• Device Model Number: 310CJ29
• Device Catalogue Number: 310CJ29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/10/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 50