MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC; HEART-VALVE, REPLACEMENT

Model Number	305U23
Medical Device Problem Codes	Calcified (1077); Biocompatibility (2886); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Medtronic received information that 9 years 4 months post implant of this 23mm aortic bioprosthetic valve, the valve was explanted and replaced with a non-medtronic bioprosthetic valve due to stenosis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the sewing ring was removed and all leaflets were excised, which likely occurred during the explant process.The leaflets were stiff but slightly flexible in areas with no visible calcification or host tissue.Due to the excised leaflets, coaptation could not be assessed.Extensive extrinsic calcification nodules appeared to have originated from the right/left commissure extending onto the left cusp.Traces of calcification were also noted on the right/non-coronary and left/non-coronary commissures.Radiography revealed calcification on the right/left, left/non-coronary, and right/non-coronary commissural areas extending towards the right and left outflow rails.From the inflow tract, thick off-white pannus remained attached to margin of attachment extending to the inferior coaptive areas.From the outflow, glistening off-white pannus adhered to left outflow rail.An unknown amount of pannus appears to have been removed on the inflow and outflow during explant.Conclusion: 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 device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The cause of the stenosis would be pannus affecting leaflet mobility.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC
• Common Device Name: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9205118
• Report Number: 2025587-2019-03179
• Device Sequence Number: 13565192
• Product Code: DYE
• UDI-Device Identifier: 00885074253305
• UDI-Public: 00885074253305
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2015
• Device Model Number: 305U23
• Device Catalogue Number: 305U23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 04/11/2020
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR