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

Model Number	310C25
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Codes	Corneal Pannus (1447); Mitral Insufficiency (1963); Mitral Valve Prolapse (2471)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 305u221, serial/lot #: (b)(4), ubd: 14-oct-2015, udi#: (b)(4).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 eight years and one month post implant of these aortic and mitral bioprosthetic valves, the valves were explanted due to increased gradients.Upon explant, the surgeon noted pannus on the inflow tract of both valves.Additionally, one of the mitral valve leaflets was prolapsed, causing wide open insufficiency.The 25mm mitral valve was replaced with a 27mm valve of the same model, and the 21mm aortic valve was replaced with a valve of the same size and model.No additional adverse patient effects were reported. .

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8288484
• Report Number: 2025587-2019-00382
• Device Sequence Number: 16759945
• Product Code: LWR
• UDI-Device Identifier: 00613994689139
• UDI-Public: 00613994689139
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 01/30/2019

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: 05/20/2015
• Device Model Number: 310C25
• Device Catalogue Number: 310C25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/30/2019
• 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: 75 YR
• Patient Weight: 54