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

Model Number	305C25
Medical Device Problem Codes	Gradient Increase (1270); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Regurgitation (1716); No Information (3190)
Date of Event	06/12/2019
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 and 7 months post implant of this aortic bioprosthetic valve, a transcatheter valve was implanted valve-in-valve.The reason for intervention was not reported.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Additional information was received that the valve was replaced due to high gradients with a mean gradient of 44mhg.The valve also had a mild "leak".No additional adverse patient effects were reported. .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: 8768242
• Report Number: 2025587-2019-02168
• Device Sequence Number: 2014335
• Product Code: DYE
• UDI-Device Identifier: 00885074133133
• UDI-Public: 00885074133133
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: 03/08/2011
• Device Model Number: 305C25
• Device Catalogue Number: 305C25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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: 72 YR