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

Model Number 310CJ31

Device Problems Biocompatibility (2886); Material Deformation (2976); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Hematoma (1884); Tricuspid Regurgitation (2112); Regurgitation (2259); No Information (3190)

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

Medtronic has attempted to confirm clarification around the reported "structural valve dysfunction", but no response has been received to date.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 nine years and ten months post implant of this bioprosthetic valve implanted in the tricuspid position, it was explanted due to "structural valve dysfunction".It was replaced with a non-medtronic valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the there was mild tricuspid regurgitation prior to explant.Additionally, the septal leaflet of the explanted valve was hypertrophic and had "mild" decrease in mobility.The mobility of the other two leaflets was not affected.The maximum blood velocity was 1.5 m/sec.The average gradient was 2.4mmhg.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the sewing ring had damage consistent with cauterization, exposing sections of the stent.The valve was distorted (oval shaped).All leaflets were in the closed position, however, due to pannus encroaching onto the superior coaptive area of the right non-coronary commissure, there was a gap in the free margin between the right and left cusps.All leaflets were slightly stiff but flexible.The inflow view noted intracuspal hematomas in the inferior coaptive areas of each cusp, as well as in the inflow margin of attachment of the non-coronary cusp (nc).The outflow view identified intracuspal hematomas along all cusps.The non-coronary right commissure was intact with pannus covering the superior coaptive area of the leaflets.The non-coronary left and left right commissures were intact.No commissure dehiscence was noted.From the inflow aspect, a thin layer of glistening pannus was observed along the base stitching.The non-coronary right commissure exhibited pannus over the superior coaptive area extending onto the outflow rail of the right cusp (rc) and onto the outflow margin of attachment and aortic wall.A thin layer of pannus was observed along the aortic wall of the non-coronary cusp (nc).Overall, an unknown amount of pannus appeared to have been removed during the explant procedure.Radiologic evaluation confirmed calcification on the left right commissure, non-coronary right commissure extending to the right cusp (rc) outflow rail.Conclusion: per the instructions for use (ifu), this valve is "indicated for patients who require replacement of their native or prosthetic aortic and/or mitral valves.¿ this valve was reported to be implanted in the tricuspid position.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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the sewing ring had damage consistent with cauterization, exposing sections of the stent.The valve was distorted (oval shaped).All leaflets were in the closed position, however, due to pannus encroaching onto the superior coaptive area of the right non-coronary commissure, there was a gap in the free margin between the right and non-coronary cusps.All leaflets were slightly stiff but flexible.The inflow view noted intracuspal hematomas in the inferior coaptive areas of each cusp, as well as in the inflow margin of attachment of the non-coronary cusp (nc).The outflow view identified intracuspal hematomas along all cusps.The non-coronary right commissure was intact with pannus covering the superior coaptive area of the leaflets.The non-coronary left and left right commissures were intact.No commissure dehiscence was noted.From the inflow aspect, a thin layer of glistening pannus was observed along the base stitching.The non-coronary right commissure exhibited pannus over the superior coaptive area extending onto the outflow rail of the right cusp (rc) and onto the outflow margin of attachment and aortic wall.A thin layer of pannus was observed along the aortic wall of the non-coronary cusp (nc).Overall, an unknown amount of pannus appeared to have been removed during the explant procedure.Radiologic evaluation confirmed calcification on the left right commissure, non-coronary right commissure extending to the right cusp (rc) outflow rail.Conclusion: per the instructions for use (ifu), this valve is "indicated for patients who require replacement of their native or prosthetic aortic and/or mitral valves.¿ this valve was reported to be implanted in the tricuspid position.Reduced performance of the valve is attributed to host tissue overgrowth (pannus) and calcification.These findings are generally considered patient-related conditions.Corrected from previously submitted regulatory report 2025587-2018-02901, follow up 002 (device evaluation).Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 8024624
• MDR Text Key: 125667207
• Report Number: 2025587-2018-02901
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2012
• Device Model Number: 310CJ31
• Device Catalogue Number: 310CJ31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 61