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

Model Number 310CJ

Device Problems Material Distortion (2977); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Mitral Regurgitation (1964); Mitral Valve Prolapse (2471)

Event Date 08/24/2017

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 8 years 6 months post implant of this bioprosthetic valve it was explanted due to prolonged mitral regurgitation.The mitral valve was replaced with a non medtronic device.The physician elected to incidentally replace the aortic valve at the same time to avoid any future surgery.The physician confirmed there was no issue with the aortic valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed the valve was slightly distorted; oval shaped, and the stent posts were slightly deflected.All leaflets were in the closed position, however, due to dehiscence at the left right commissure, the right cusp was prolapsed, crowding the leaflets at the inflow view.All leaflets were stiff but slightly flexible except where pannus was observed.All leaflets were intact except where the commissure was detached/dehisced.Due to pannus at the non-coronary left commissure and the dehisced commissure at the right left stent post, the leaflets were crowded, and the right cusp was prolapsed.The right left commissure was found dehisced, possibly related to separation of the layers of aortic wall behind the commissure.The sutures holding the aortic wall to the stent post were intact.Minimal calcification and possible tissue deterioration was observed at the non-coronary right commissure.The non-coronary left commissure was covered with pannus where leaflet attachments could not be viewed.Pannus was observed all around the outflow aspect of the sewing ring, extending to the base stitching to the inflow margin of the attachment, encroaching up to 4 mm on to the cusps and into the inferior coaptive areas between all cusps.The pannus appeared to have restricted leaflet movement.Pannus covered the non-coronary left commissure extending to the outflow rail along the left cusp.Remnants of pannus was observed on the outflow rail of the left cusp and extending to the non-coronary left stent post and right left stent post.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Radiography revealed calcification at the right left commissure (dehisced area) and at the non-coronary right commissure.Conclusion: reduced performance of the valve is attributed to calcification and host tissue overgrowth.These findings are generally considered a patient-related condition.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7147428
• MDR Text Key: 95804272
• Report Number: 2025587-2017-02564
• 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: 01/23/2018

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: 03/28/2012
• Device Model Number: 310CJ
• Device Catalogue Number: 310CJ27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 01/17/2018; 01/22/2018
• Supplement Dates FDA Received: 01/22/2018; 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2007
• 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: 74 YR
• Patient Weight: 64