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

Model Number	LXA19
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	09/25/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed that a patient who had a mitroflow aortic pericardial valve lxa19 implanted on (b)(6) 2013, due to aortic root aneurysm with aortic regurgitation with connective tissue disorder, developed a progressive aortic stenosis and mitral regurgitation.On (b)(6) 2015, she underwent a re-do sternotomy to replace the mitroflow valve with a 19 mm magna ease.As reported, patient died on (b)(6) 2021 due to systolic heart failure due to diastolic heart failure due to valve (magna ease) dysfunction.

• 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, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 15633928
• Report Number: 3019892983-2022-01046
• Device Sequence Number: 7975047
• Product Code: LWR
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)171231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2022
• Report Date (Section F): 09/21/2022

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: 12/31/2017
• Device Model Number: LXA19
• Device Catalogue Number: LXA19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/21/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2022
• 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: 15 YR
• Patient Sex: Female