MAUDE Adverse Event Report: HEART VALVES SANTA ANA MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, REPLACEMENT

Model Number	305C225
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Aortic Dissection (2491)
Date of Event	07/28/2018
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 seven years and four months post implant of this aortic bioprosthetic valve, the valve was explanted and replaced with another aortic bioprosthetic valve of the same size and model.The reason for the explant was reported as aortic dissection and severe aortic insufficiency.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that the aortic dissection occurred in the ascending aorta and tore down to the previously implanted bioprosthetic valve.The surgeon was repairing the dissection and determined the best way to repair it was to remove the bioprosthetic valve.The valve was replaced with a new bioprosthetic valve and a non-medtronic graft, that were sutured together and implanted as one conduit.No additional adverse patient effects were reported.  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): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7820597
• Report Number: 2025587-2018-02251
• Device Sequence Number: 14134521
• Product Code: DYE
• UDI-Device Identifier: 00613994760715
• UDI-Public: 00613994760715
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 09/19/2018

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: 06/09/2015
• Device Model Number: 305C225
• Device Catalogue Number: 305C225
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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: 77 YR