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

Model Number LXA21

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer is presently following up to retrieve additional information on the number of patients/devices involved.For this reason, only one vigilance report was submitted at this time.Up to date, no further information was provided on the events, devices involved and patient's impact/outcome.Should any further information be received, identifying the number of devices involved, separate reports will be submitted for each device.Valve-in-valve procedure performed.

Event Description

The manufacturer was informed on few failed mitroflow devices requiring valve-in-valve procedures.No further information provided on the device malfunction noted, implant time of the devices and outcome of the patients.

Manufacturer Narrative

The information received for the first patient was associated with this reporting activity.Since a second reportable incident was identified with another device (different patient), thus a separate mdr was submitted (ref 3004478276-2022-00119).A third device (third patient) was also identified, but the information received do not meet the criteria for a reportable incident, thus no report was submitted for this case.No further events were received from the hospital.Since the device was not explanted, no inspection can be performed on the device and a definitive root cause cannot be established at this time.As reported in the scientific literature, structural valve deterioration is the major cause of failure of bioprosthetic heart valves.This patient has strong risk factors and significant clinical history (i.E.History of heart failure with preserved ejection fraction, left ventricular hypertrophy, dyslipidemia, hypertension, and severe copd) that may have contributed to the structural valve deterioration observed in this mitroflow valve.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.

Event Description

The manufacturer was informed on few failed mitroflow devices requiring valve-in-valve procedures.No further information provided on the device malfunction noted, implant time of the devices and outcome of the patients.The manufacturer obtained additional information identifying that one of these patients had a mitroflow valve lxa21 implanted on (b)(6) 2011.The patient¿s preoperative diagnosis was of native aortic valve stenosis.The patient tolerated the procedure well and was taken to the recovery room in critical but stable conditions.The follow up visit performed in november 2011 confirmed a good function of the mitroflow valve implanted.The echo also showed a mild, concentric left ventricular hypertrophy (lvh) with normal ventricular systolic function and estimated ef of 55%.The echo performed in (b)(6) 2013 showed the presence of mild, concentric lvh, ef 55-60%.The mitroflow valve showed a normal functionality.No significant change is identified compared to the echo performed in (b)(6) 2011.The echo reports received for the exams performed in (b)(6) 2016 are not fully readable (sections related to the aortic valve are cut out).However, it is possible to identify changes in the functionality of the mitroflow valve (mild aortic regurgitation identified, not possible to confirm if aortic stenosis also present).Moderate concentric lvh, with ef ranging from 55% to 65% is also identified in both exams.The tee performed in (b)(6) 2018 showed a mitroflow valve dysfunction with a mean/peak gradient of 26/52.42mmhg (increased from previous studies).One of the leaflets is reportedly immobile.There is moderate to severe intravalvular aortic regurgitation.A normal lv systolic function is reported with ef 55-60%.The patient has been having symptoms of congestive heart failure for which the patient was medically optimized and referred for right and left heart catheterization (performed on (b)(6) 2018).On (b)(6) 2019 the patient was treated with a transcatheter aortic valve replacement with medtronic #23 evolute r valve.The preoperative diagnosis was of severe aortic valve insufficiency and aortic stenosis post aortic valve replacement with a #21 mitroflow valve.The patient was discharged on (b)(6) 2019.

• Brand Name: MITROFLOW LXA AORTIC PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13085384
• MDR Text Key: 284978089
• Report Number: 3004478276-2021-00296
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

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
• Device Operator: Health Professional
• Device Model Number: LXA21
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/24/2021
• Supplement Dates Manufacturer Received: 12/29/2021
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 54 KG