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

Model Number 310C31

Device Problems Hole In Material (1293); Material Distortion (2977); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Cusp Tear (2656)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

The device has been returned for analysis.Following the completion of the analysis a follow up report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 11 years and 11 months post implant of this 31 mm mitral bioprosthetic valve, the valve was explanted and replaced with a 29 mm valve of a different model due to a torn leaflet, regurgitation and stenosis of the 31 mm valve.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed the sewing ring had been cut during the explant procedure.Two loose pieces of the sewing ring were returned, and a small piece of pannus was returned.The valve was slightly distorted; oval shaped.The non-coronary cusp and left cusp were in the closed position.The right cusp was in the open position.All leaflets were flexible except in areas where there was pannus and calcification.The left cusp exhibited extrinsic calcification with tissue deterioration noted on the lunula and on the tissue closest to the commissures.A tear was noted on the cusp adjacent to the base stitching that appeared to be related to the pannus overgrowth.The non-coronary cusp was stiff due to pannus extending from the outflow rail and onto the leaflet and up to the free margin.The right cusp exhibited a hole/abrasion that appeared to be due to contact with a chordae tendineae.The right left commissure exhibited tissue deterioration due to calcification.Pannus was also observed at the commissure area, extending from the stent post.The right non-coronary commissure was encapsulated with pannus.Leaflet attachment could not be assessed due to the pannus overgrowth.A chordae tendineae was found on top of the stent post.The left non-coronary commissure was also encapsulated by pannus.Tissue deterioration due to calcification was observed on the tissue of the left cusp closest to the commissure.Pannus was observed on sections of the sewing ring on the inflow, over the tissue and base stitching, up to 3 mm onto the noncoronary cusp.Pannus on the outflow remained attached to the remaining sewing ring, along the outflow rails adjacent to all cusps, encapsulating the right non-coronary stent post and left non-coronary stent post which extended onto the commissures.Remnants of pannus were observed on the right left commissure.Pannus encroached onto the non-coronary cusp from the outflow rail to the free margin and was observed on the loose sewing ring pieces.Unknown amount of pannus may have been removed during the explant procedure.Radiography confirmed calcification on the lunula of the left cusp and at the left non-coronary 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.

• 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: 7186530
• MDR Text Key: 97117688
• Report Number: 2025587-2018-00160
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00885074247878
• UDI-Public: 00885074247878
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2010
• Device Model Number: 310C31
• Device Catalogue Number: 310C31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2005
• 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: 70 YR
• Patient Weight: 64