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

Model Number 310CJ25

Device Problems Degraded (1153); Incomplete Coaptation (2507); Insufficient Information (3190); Material Split, Cut or Torn (4008)

Patient Problems Foreign Body Reaction (1868); Insufficient Information (4580)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, 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 an unknown duration post implant of this bioprosthetic mitral valve, it was explanted and replaced with a non-medtronic valve.The valve was replaced due to unspecified structural valve dysfunction.The patient tolerated the procedure well.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the replacement was 9 years and 3 months post implant.No additional adverse patient effects were reported.D4: model #, catalog #, serial #, udi #, expiration date added d6a: implanted date added d9: device available for evaluation? corrected e1: facility name corrected h3: device evaluated? corrected h4: device mfg date added h6: coding corrected medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed evidence of cauterization along the sewing ring.All leaflets were flexible except where host tissue extends on the inflow and outflow.Tissue deterioration was observed on the right cusp and left cusp approaching the right/left commissure.The free margin of the left cusp is rolled over onto the lunula.A tear on the tunica of the left cusp, along the inflow margin of attachment, appears to be associated with the removal of host tissue during explant.The non-coronary cusp was in the closed position.Due to the tissue deterioration on the right and left cusps, the right cusp was prolapsed.Tissue deterioration observed on the right and left cusps of the left/right commissure.The right/non-coronary and left/non-coronary commissures were intact.Thick glistening off-white pannus covers the tissue and base stitching, into all inferior coaptive areas, and onto all cusps reducing the inflow orifice area and possibly restricting leaflet movement.Remnants of glistening off-white pannus remain attached to the existing sewing ring on the outflow, extending to the right cusp and non-coronary cusp outflow rails slightly covering the top of the left/non-coronary commissure.An unknown amount of pannus ap pears to have been removed during explant.Radiography did not reveal calcification on the returned valve.Conclusions: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Structural valve deterioration (svd) is a known adverse event for bioprosthetic heart valves.Based on the risk analysis and historical trend, cuspal tear is a common form of svd which could lead to regurgitation.Pannus, a patient-related condition, would be the common cause for immobile leaflet, a common form of svd which could lead to stenosis.As the returned valve had extensive pannus around the functional areas of the valve, the leaflet and commissure shape and mobilities had been adversely impaired causing prolapse and tears in the tissue.H6: coding updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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: 11265639
• MDR Text Key: 229823877
• Report Number: 2025587-2021-00399
• 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: 06/18/2021

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: 03/03/2016
• Device Model Number: 310CJ25
• Device Catalogue Number: 310CJ25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 02/03/2021; 05/27/2021
• Supplement Dates FDA Received: 02/04/2021; 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention