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

Model Number	305U229
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Corneal Pannus (1447); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Cusp Tear (2656); No Information (3190)
Date of Event	09/12/2018
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 one year and four months post implant of this 29mm aortic bioprosthetic valve, the valve was explanted and replaced with a valve of the same size and model.The reason for explant is unknown.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that the valve was explanted due to stenosis and severe regurgitation.Upon explant, the surgeon noted pannus formation on the inflow tract as well as torn leaflets.The surgeon was unsure if the torn leaflets were due to the explant procedure itself.No additional adverse patient effects were reported.  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.Reduced performance of the valve may be attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Patient codes updated in section.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 VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7924623
• Report Number: 2025587-2018-02597
• Device Sequence Number: 1643709
• Product Code: LWR
• UDI-Device Identifier: 00643169001480
• UDI-Public: 00643169001480
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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: 01/18/2022
• Device Model Number: 305U229
• Device Catalogue Number: 305U229
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/31/2018
• 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: 36 YR
• Patient Weight: 100