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

Model Number	305U
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/26/2017
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 a 19mm valve of the same model.The reason for the explant was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7052255
• Report Number: 2025587-2017-02251
• Device Sequence Number: 903285
• Product Code: LWR
• UDI-Device Identifier: 00643169595002
• UDI-Public: 00643169595002
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

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: 06/06/2022
• Device Model Number: 305U
• Device Catalogue Number: 305U221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 12/08/2017
• 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: 78 YR