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

Model Number 310CJ29

Device Problems Folded (2630); Material Distortion (2977); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Abrasion (1689); Hematoma (1884); Prolapse (2475); Cusp Tear (2656); No Information (3190)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.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 mitral bioprosthetic valve, the valve was explanted and replaced with a non-medtronic valve due to a torn leaflet.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection revealed the valve was slightly distorted and oval shaped with deflected stent posts.All three leaflets were in the closed position, however, the free margins overlapped at the center of coaptation.The leaflets appeared crowded where the non-coronary (ncc) cusp was found prolapsed due to a tear at the commissure.The ncc exhibited a tear associated with pannus along the non-coronary right commissures.The ncc also exhibited an abrasion on the lunula associated with the leaflets touching against each other at the center of coaptation.A hematoma was observed on the left cusp (lc) at inflow.The lc exhibited an abrasion on the lunula that was also associated with the leaflets touching against each other at the center of coaptation.The right cusp (rc) exhibited a fold where it touched the stent post in the open position.No hole/abrasion was observed, however the tissue appeared thin on the folded area.All commissures were intact and attached to the aortic wall.A thin layer of pannus lined the base stitching of all leaflets at inflow.Pannus remnants were found attached on the sewing ring extending to the nc outflow rail.All commissures exhibited pannus on the superior coaptive areas.Pannus was found on the aortic wall at all commissures extending to the leaflets.Pannus was observed on the torn edge of the nc leaflet.Remnants of pannus were observed on the non-coronary left stent post.An unknown amount of pannus may have been removed on the inflow and outflow during explant.There was no commissure dehiscence observed.Radiography did not reveal calcification on the valve leaflets.Conclusion: reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient -related condition.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 VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7442766
• MDR Text Key: 105897623
• Report Number: 2025587-2018-00913
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2013
• Device Model Number: 310CJ29
• Device Catalogue Number: 310CJ29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention