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

Model Number 305U2J23

Device Problems Calcified (1077); Material Split, Cut or Torn (4008)

Patient Problems Foreign Body Reaction (1868); Cusp Tear (2656)

Event Date 02/09/2021

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 9 years and 8 months post implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with a non-medtronic valve due to a torn valve leaflet.The reason for the replacement was not reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that most of the sewing ring was removed, likely a result of explant procedure.All leaflets are stiff but slightly flexible in some areas with no visible calcification.Extensive calcification was observed on all leaflets causing tissue deterioration on all cusps.All leaflets were in a closed position.Tissue deterioration due to calcification was observed on all commissures, to a lesser extent on the left/non-coronary commissure.From the inflow, glistening off-white pannus partially lined the inflow base stitching, covering the tissue and extending approximately 6mm on the right cusp and 3mm on the non-coronary cusp.Multiple pledgets were observed on the pannus overgrowth.An unknown amount of pannus appears to have been removed on the outflow during explant.Radiography revealed extensive calcification on the returned valve, on all leaflets and commissural areas.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.With the results from the analysis, extensive damage to the valve was caused by a combination of calcification and pannus.Calcification and pannus are inherent risks of bioprosthetic valve replacement and can be patient-related conditions.Based on the risk analysis and historical trend, cuspal tear is a common form of structural valve dysfunction which could lead to regurgitation.D9: device available for evaluation? updated e1: facility name updated g2: report source corrected 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 ULTRA 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: 11332996
• MDR Text Key: 231996061
• Report Number: 2025587-2021-00557
• 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: 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: 11/18/2015
• Device Model Number: 305U2J23
• Device Catalogue Number: 305U2J23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2021
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention