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

Model Number 310CJ27

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Aneurysm (1708); Cusp Tear (2656); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.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 11 years and 4 months post implant of this 27mm mitral bioprosthetic valve, it was explanted and replaced with a non-medtronic valve.It was reported that moderate regurgitation was present with a valve perforation and leaflet tear.An aneurysm in the mitral valve location was also present.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that all leaflets were in the closed position with a gap between the non-coronary cusp and the left cusp.All leaflets were slightly stiff yet pliable in areas with no visible calcification.The left cusp was intact.Calcification was observed on the right cusp and non-coronary cusp, which appeared to contribute to the deterioration of adjacent tissue.An abrasion on the lunula of the right cusp was observed, possibly due to contact with the outflow railing.The right cusp was prolapsed on the inflow.The left/right and left/non-coronary commissures were intact.Tissue deterioration due to calcification was observed on the right/non-coronary commissure.On the inflow, glistening light tan pannus noted along the sewing ring extending to the margin of attachment of all cusps.On the outflow, traces of glistening off-white pannus remained attached to the non-coronary outflow rail extending to the backs of the left non-coronary stent post.Radiography revealed moderate calcification on the left/right and right/non-coronary commissural areas.Conclusions: since the valve has been implanted for over 11 years, it is very unlikely that the regurgitation is due to any potential manufacturing issue.Based on the risk analysis and historical trend, cuspal tear and/or commissure dehiscence were the most common mechanisms which could lead to regurgitation.Calcification would be one of the common causes for these failure modes.With the results of the analysis from the returned device, calcification was present on the right cusp and non-coronary cusp adjacent to the tissue deterioration and on the commissures.Pannus was also present on the device, further adding to disruption of valve functional areas.Calcification and pannus are inherent risks of bioprosthetic valve replacement and can be considered patient-related conditions.From the available information, a conclusive cause of the aneurysm could not be determined.An aneurysm can occur due to user technique or patient-related factors.D4: expiration date, serial #, udi # added d9: device available for evaluation? updated e1: facility name and phone number corrected e2: hcp? corrected e3: occupation corrected 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.

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11929753
• MDR Text Key: 254019307
• Report Number: 2025587-2021-01765
• 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
• Report Date: 08/27/2021

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: 12/10/2014
• Device Model Number: 310CJ27
• Device Catalogue Number: 310CJ27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 44