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

Model Number	305C
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/08/2018
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 immediately post implant of this 21mm aortic bioprosthetic valve, the valve was explanted and replaced with 19mm valve of the same model.The reason for the explant was not reported. no additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that the physician reported there was no issue at all with the bioprosthetic valve.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7654233
• Report Number: 2025587-2018-01654
• Device Sequence Number: 16557057
• Product Code: DYE
• UDI-Device Identifier: 00643169594685
• UDI-Public: 00643169594685
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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: 03/14/2023
• Device Model Number: 305C
• Device Catalogue Number: 305C221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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: 66 YR