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

Model Number	305U221
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 approximately one year post implant of this 21mm aortic bioprosthetic valve, the valve was explanted and replaced with a 23mm bioprosthetic valve of a different model due to patient prosthesis mismatch (ppm). no additional adverse patient effects were reported.One coronary artery bypass graft was used during the redo aortic valve replacement (avr).

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8139091
• Report Number: 2025587-2018-03321
• Device Sequence Number: 16675417
• Product Code: DYE
• UDI-Device Identifier: 00643169594944
• UDI-Public: 00643169594944
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 01/10/2022
• Device Model Number: 305U221
• Device Catalogue Number: 305U221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/06/2018
• 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: 60 YR
• Patient Weight: 90