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

Model Number 31027

Device Problems Calcified (1077); Degraded (1153); Material Deformation (2976); Mechanical Jam (2983); Mechanics Altered (2984); Naturally Worn (2988); Material Split, Cut or Torn (4008)

Patient Problems Host-Tissue Reaction (1297); Mitral Regurgitation (1964)

Event Date 03/12/2020

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 approximately 10 years post implant of this 27mm mitral bioprosthetic valve, mitral regurgitation was noted, which could lead to heart failure.The surgeon believed that since the heart was small in size, the tip of the stent post might have been touching the septum which may have led to a cuspal tear.As a result, 6 months later the valve was explanted and replaced with a 29mm non medtronic valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the valve appeared distorted in an oval shape, and the sewing ring appears to have been cauterized during the explant process.The right cusp and left cusp appeared to be in the closed position with the non-coronary cusp appearing open and making contact with the outflow rail.All leaflets were slightly stiff but flexible except where host tissue extends on the inflow and outflow.Large tears on the right cusp and left cusp appeared to be associated with deterioration due to calcification.An abrasion through the free margin and lunula of the non-coronary cusp was noted, possibly associated with outflow rail contact.Thick calcification observed on the right/left commissure appeared to restrict left cusp and right cusp leaflet mobility.A layer of off-white pannus encapsulates the right/non-coronary and left/non-coronary commissures, thus the condition of the commissures cannot be determined.Glistening off-white pannus covered the existing sewing ring on the inflow.A layer of off-white pannus lined the right, left, and non-coronary outflow rails extending to the back of all stent posts.An unknown amount of pannus may have been removed during explant.Radiography revealed calcification on the right/left commissure, right/non-coronary commissure, and left cusp outflow rail.Conclusions: since the valve was implanted for approximately 10 years, it is highly unlikely that the regurgitation is due to any potential manufacturing issue.The returned valve showed evidence of deterioration due to calcification, which was present on the right/left commissure.An abrasion through the free margin and lunula of the non-coronary cusp was noted, possibly associated with outflow rail contact.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 cuspal tear and/or commissure dehiscence, and is often considered a patient-related condition.A5: patient race added.D4: serial # added.D10: device available for evaluation updated.E1: facility name updated.E2: hcp? updated.E3: occupation updated.H3: device evaluated? updated.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 PORCINE 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: 9968826
• MDR Text Key: 187925644
• Report Number: 2025587-2020-01297
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31027
• Device Catalogue Number: 31027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR