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

Model Number 310CJ

Device Problems Occlusion Within Device (1423); Material Distortion (2977)

Patient Problems Corneal Pannus (1447); Hematoma (1884); Mitral Valve Stenosis (1965); Thrombus (2101); Cusp Tear (2656)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

Multiple attempts have been made to obtain additional information without success at this time.If additional information is received, 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 9 years 9 months post implant of this bioprosthetic valve it was explanted due to prolonged stenosis.The valve was replaced with a non medtronic device.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual evaluation showed the valve was slightly distorted; oval shaped.The right cusp was in the closed position while the left cusp (lc) and non-coronary (nc) cusp were in an open position.All leaflets were stiff but slightly flexible.The right cusp was partially torn from the left right commissure (lr).A tear was also observed on the lunula of the right cusp.There was an abrasion of the right cusp due to pannus of the lr commissure.Minimal thrombus was observed on the base stitching of the nc cusp.A hematoma was noted on the inflow of the rc.Pannus was observed on all commissures.All leaflets were attached to commissures except the rc at the lr commissure.Pannus encapsulated the lr stent post and was present around the outflow sewing ring adjacent to the lr stent post to the rnc stent post.Pannus was observed on all outflow rails to the base stitching and was also present on the inflow sewing ring.An unknown amount of pannus appeared to have been removed during explant; which would have significantly impaired the leaflet mobility.Radiography revealed no calcification.Conclusion: reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient -related condition.The impairment of leaflet mobility may have led to the thrombus formation on the outflow of the valve.In addition, cuspal tear / abrasion was observed due to pannus overgrowth on the commissure, which may have caused the stenosis.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: 7147402
• MDR Text Key: 95802545
• Report Number: 2025587-2017-02563
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 310CJ
• Device Catalogue Number: 310CJ29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Date Device Manufactured: 12/20/2005
• 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
• Patient Age: 73 YR