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

Model Number	305C227
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Unspecified Infection (1930)
Date of Event	08/07/2018
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 2 months post implant of this 27mm aortic bioprosthetic valve, it was explanted and replaced with a 27mm aortic bioprosthetic valve due to infection.The valve was sent for culture and the results were positive for aspergillus.The patient experienced shortness of breath/tiredness as a result.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The reported organism (aspergillus) could be rendered non-viable to the sterilization process during manufacturing.Therefore, it is unlikely that the organism originated from the device and/or manufacturing valve process.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.

• 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: 7880390
• Report Number: 2025587-2018-02431
• Device Sequence Number: 1819409
• Product Code: DYE
• UDI-Device Identifier: 00643169594715
• UDI-Public: 00643169594715
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/22/2018

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: 03/07/2023
• Device Model Number: 305C227
• Device Catalogue Number: 305C227
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/22/2018
• 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: 78 YR