MAUDE Adverse Event Report: CORCYM CANADA CORP. MITROFLOW LXA AORTIC PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number	LXA23
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa23, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a lxa23 mitroflow aortic pericardial heart valve at the time of manufacture and release.
Event or Problem Description
On (b)(6) 2021, an event of svd on a mitroflow valve was reported.The surgeon provided 31 serial numbers, and was inquiring about which model (dla or lxa) each valve was, and also which valve has the old or the new anticalcification method.This case refers to the 18th serial # provided.Implant time is unknown.

• Brand Name: MITROFLOW LXA AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12422672
• Report Number: 1718850-2021-01185
• Device Sequence Number: 11608783
• Product Code: LWR
• UDI-Device Identifier: 00896208000115
• UDI-Public: (01)00896208000115(240)LXA23(17)160131
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2021
• Report Date (Section F): 08/05/2021

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: No Information
• Device Model Number: LXA23
• Device Catalogue Number: LXA23
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/05/2021
• Date Report to Manufacturer: 08/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2021
• 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: Other