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

Model Number 310CJ25

Device Problems Break (1069); Material Twisted/Bent (2981); Naturally Worn (2988); Material Split, Cut or Torn (4008)

Patient Problems Host-Tissue Reaction (1297); Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/11/2020

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 9 years and 4 months post implant of this 25mm bioprosthetic mitral valve, it was explanted and replaced with a 23mm non-medtronic bioprosthetic valve.The reason for replacement was reported as severe mitral stenosis and a torn leaflet.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the sewing ring was removed exposing the stent, which was likely a result of the explant process.There was a break on the exposed stent with adjacent damage to the existing sewing ring.All leaflets were twisted and in the closed position.All leaflets were slightly stiff but flexible except where host tissue extends on the inflow and outflow.A leaflet tear was noted on the non-coronary cusp near the margin of attachment down to the belly of the leaflet.The base stitching was intact.Thinning of the tissue was noted on the lunula of the left cusp.Leaflet deterioration was noted on the right cusp adjacent to the right/left commissure appearing to result from the leaflet opening and closing against pannus growth on the right/left commissure.An off-white layer of pannus encapsulated the right/left and left/non-coronary commissures, while the right/non-coronary commissure was intact.From the inflow, pannus remained attached to the sewing ring, extending up to 4mm of the right/left inferior coaptive area.Pannus remained attached to the right cusp and left cusp outflow rails as well as on the back of all stent posts.An unknown amount of pannus may have been removed during explant.Radiography did not reveal calcification.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.The pannus growth on the returned valve was pronounced, which led to damage of the right/left and left/non-coronary commissures.This pannus growth damage resulted in leaflet deterioration and tearing.Pannus formation is also a common cause of stenosis, and is often considered a patient-related condition.D4: serial #, udi #, expiration date added, h3: device evaluated? updated, h4: device mfg date added, 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.

Manufacturer Narrative

B5: desc evt problem corrected 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.

Event Description

Medtronic received information that 9 years and 4 months post implant of this 25mm bioprosthetic mitral valve, it was explanted and replaced with a 23mm non-medtronic bioprosthetic valve.The reason for replacement was reported as severe mitral regurgitation caused by a torn leaflet.No additional adverse patient effects were reported.

• 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: 9957284
• MDR Text Key: 187540843
• Report Number: 2025587-2020-01238
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2015
• Device Model Number: 310CJ25
• Device Catalogue Number: 310CJ25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 50