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

Model Number	305C219
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/17/2020
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 from the patient's mother that an unknown duration post implant of this 19mm bioprosthetic aortic valve implanted in the mitral position of a (b)(6)-month-old pediatric patient, there was a "problem with his mitral valve which ultimately he needed a heart transplant".It is unknown if the mitral valve noted was the patient's native valve or the bioprosthetic valve.It was also reported that approximately 2 months prior to implant of the bioprosthetic valve, the patient's pacemaker was replaced which caused "heart failure".No additional adverse patient effects were reported.

• 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: 10281784
• Report Number: 2025587-2020-02243
• Device Sequence Number: 3106668
• Product Code: DYE
• UDI-Device Identifier: 00643169594678
• UDI-Public: 00643169594678
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: 05/29/2023
• Device Model Number: 305C219
• Device Catalogue Number: 305C219
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/16/2020
• 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: 47 MO