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

Model Number 310CJ27

Device Problems Calcified (1077); Material Separation (1562); Incomplete Coaptation (2507); Biocompatibility (2886); Material Deformation (2976); Insufficient Information (3190)

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

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

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 approximately nine years post implant of this bioprosthetic valve, the valve was explanted and replaced with a bioprosthetic valve of same size and model.The reason for the explant was not reported. it was reported that there was concern with regards to the durability of the valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was slightly distorted.Visual inspection identified damage to the sewing ring, bias cloth and stent cloth.The stent cloth damage exposed the left right stent post.The damage is consistent with damage that could occur during explant.All leaflets were in the closed position; however, due to dehiscence in the right left commissure, the right cusp was prolapsed, crowding the right and left leaflets.All leaflets were slightly stiff but flexible, except where host tissue extended on the inflow.The right cusp (rc) prolapse was believed to be a result of the dehisced right left commissure which pressed the right and left cusps together.Due to the dehiscence, and resulting prolapse, the leaflets were overcrowded.The rc and left cusp (lc) exhibited tissue degeneration and tears at the right left commissure.On the inflow, marginal intracuspal hematoma was noted on the rc.The left non-coronary commissure was intact.The right left commissure dehiscence was possibly related to separation of the layers of the aortic wall behind the commissure.One partially visible suture was intact.The beginning of a dehiscence was noted at the superior coaptive area of the right non-coronary commissure.Remnants of pannus remained attached to the sewing ring extending up to 5mm on the inflow.Traces of pannus were noted around the sewing ring, adjacent to the tear-like damage.A thick layer of host tissue was observed posterior to the right non-coronary stent post.A thin layer of pannus was noted around the right non-coronary commissure.An unknown amount of pannus appeared to have been removed during explant.Radiography revealed calcification posterior to the right non-coronary commissure and non-coronary cusp.Conclusion: based on the product return analysis, distortion of the annular ring may have altered the stress placed on the commissures and leaflets.This alteration of the stress may have played a role in the dehiscence of a commissure.Also, the observed calcification may be another contributing factor to the commissure dehiscence.Pannus overgrowth that was observed on the inflow would have significantly impaired leaflet mobility.Reduced performance of the valve is attributed to host tissue overgrowth (pannus) and calcification.These findings are generally considered patient-related conditions.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
• Manufacturer (Section G): MEDTRONIC HEART VALVES 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: 8079743
• MDR Text Key: 127450962
• Report Number: 2025587-2018-03082
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2014
• Device Model Number: 310CJ27
• Device Catalogue Number: 310CJ27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2009
• 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