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

Model Number 310CJ27

Device Problems Degraded (1153); Material Discolored (1170); Material Separation (1562); Material Deformation (2976); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problems Corneal Pannus (1447); Hematoma (1884); Mitral Insufficiency (1963); Cusp Tear (2656)

Event Date 08/22/2018

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 9 years and 4 months post implant of this mitral bioprosthetic valve, the valve was explanted and replaced due to insufficiency from a torn leaflet.It was reported the inside of the valve stent post was discolored black.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the insufficiency was reported as moderate.Patient information added.Device information updated.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 inspection revealed the valve was slightly distorted.All leaflets were in the closed position with wavy free margins.All leaflets are slightly stiff but flexible, except where host tissue was present.The free margins of all cusps were twisted and crowded.An intra-cuspal hematoma was noted along the inflow margin of attachment of the non-coronary cusp (nc) extending onto the right and left non-coronary inferior coaptive areas.At outflow, all leaflets were slightly thickened.The left cusp (lc) was billowed and tissue deterioration was noted on the left and right cusps (rc) as a result of left right commissure dehiscence.The detachment did not expose the aortic wall; therefore, manufacturing sutures could not be assessed.The condition of the left non-coronary commissure could not be determined due to the host tissue overgrowth.The right non-coronary commissure was intact, with pannus extending onto the nc outflow rail.Traces of pannus were observed at inflow along the sewing ring.Thick, glistening, off white pannus was observed along the outflow rail of the lc extending to and encapsulating the left non-coronary commissure and back of the stent post.An unknown amount of pannus appeared to have been removed during e xplant.Radiography did not reveal calcification on the leaflets and / or host tissue.Conclusion: based on the product return analysis, the reported black discoloration inside the valve stent post and cuspal tear could not be confirmed; however, an intra-cuspal hematoma was observed along the inflow margin of attachment of the non-coronary cusp extending onto the right and left non-coronary inferior coaptive areas.The left right commissure dehiscence may have caused tissue deterioration on the left and right cusp, which could have led to regurgitation.If too much pannus covered the commissure / stent post, it is possible it could have created additional stress during valve closure by limiting the deflection of the stent posts.In this case, the pannus overgrowth may have been a contributing factor to the commissure dehiscence.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 dehiscence of the commissure.While it occurs at very low rates, commissure dehiscence is a known risk is for valve failure and is more often seen in the mitral position due to the higher closing forces on the mitral valve.Sometime patient factors such as hypertension can increase this risk.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.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: 7875243
• MDR Text Key: 120238824
• Report Number: 2025587-2018-02417
• 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
• Report Date: 02/21/2019

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: 12/17/2013
• Device Model Number: 310CJ27
• Device Catalogue Number: 310CJ27
• Device Lot Number: 27M08T2323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 11/01/2018; 01/29/2019
• Supplement Dates FDA Received: 11/07/2018; 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 54