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

Model Number	LXA25
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, an event of svd on a mitroflow lxa25 valve was reported.The implant time and patient impact are presently unknown.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa25, 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 lxa25 mitroflow aortic pericardial heart valve at the time of manufacture and release.Since the device was not returned to the manufacturer, no further investigation is possible at this time.As reported in the scientific literature, structural valve deterioration is the major cause of failure of bioprosthetic heart valves.It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this mitroflow lx valve.However, since no further information is available, a definitive root cause cannot be stated at this time.It should be noted that structural valve deterioration is listed as a possible adverse event in the mitroflow ifu.The event is, therefore, a known inherent risk of the device.The manufacturer is following up to retrieve additional information on the event reported.Should the manufacturer receive further information, an update to this reporting activity will be provided.
Additional Manufacturer Narrative
Corrected conclusion code in h6.The remainder of the information previously submitted remains unchanged.
Additional Manufacturer Narrative
Corrected sections: h3, h6 (to include codes 4114-device not returned and 3221-no findings available) since the device was not returned to the manufacturer, no further investigation is possible at this time.Based on the limited information available, it is not possible to draw a definitive conclusion to the reported event.However, from the document review performed, no manufacturing deficiencies were identified.The manufacturer has contacted the physician for further information, but none was received to date.Given that the device functionality over time, patient's clinical history and risk factors, treatment and patient's impact are unknown, the root cause remains unknown at this time.It should be noted that structural valve deterioration is listed as a possible adverse event in the mitroflow valve ifu.The event is, therefore, a known inherent risk of the device.Should any additional information be received in the future, the manufacturer will provide an update to this reporting activity.

• 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
• MDR Report Key: 12423968
• Report Number: 3004478276-2021-00243
• Device Sequence Number: 3420888
• Product Code: LWR
• UDI-Device Identifier: 00896208000115
• UDI-Public: (01)00896208000115(240)LXA25(17)140630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2021

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: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: LXA25
• Device Catalogue Number: LXA25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 09/03/2021; 10/19/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/03/2021; 10/19/2021
• 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