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

Model Number	LXA19
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Fatigue (1849)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2012, a patient received a mitroflow valve size 19 as part of an aortic valve replacement procedure.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 satisfactory conditions.The echo performed in (b)(6) 2012 showed a mitroflow valve adequately functioning (mean/peak gradients 26/45mmhg, trace of aortic valve regurgitation).Mild mitral regurgitation is noted, with mild-moderate mitral annular regurgitation.The left ventricular wall thickness is mildly increased (ef is 55-60%).The echo performed in (b)(6) 2014 showed a mitroflow valve with elevated gradients.The ef is 55-60%.The aortic valve is well seated, with no rocking motion and no paravalvular leaks.The leaflets appeared think and flexible.The mean/peak gradients were 33/56mmhg.The echo performed in dec 2016 revealed a lvef of 60-65%.The mitroflow valve appeared with elevated gradients (av mean gradient is 37mmhg).The prosthetic valve leaflets appeared thickened and calcified.There is possible prosthetic stenosis.The echo performed in (b)(6) 2017 confirmed the presence of elevated gradients in the aortic valve and possible prosthetic stenosis.The echo performed in (b)(6) 2018 showed mildly increased lv wall thickness with an lvef of 70-75%.Severe prosthetic aortic valve stenosis is identified (eoa 0.9 cm2, mean gradient is 52mmhg).The patient was treated with a valve in valve transcatheter aortic valve replacement with a medtronic #23 evolut r pro on (b)(6) 2019.The patient tolerated the procedure well and was taken to the recovery room in satisfactory conditions.The patient was discharged on (b)(6) 2019.The pre-operative note indicated that at the time of the mitroflow valve implant in 2012 there were technical difficulties secondary to a large calcium bar in the aorta above the valve annulus.The patient complained fatigue, decreased energy and activity level and exertional shortness of breath with minimal exertion.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa19, 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 lxa19 mitroflow aortic pericardial heart valve at the time of manufacture and release.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 and the principal underlying pathologic process is cuspal calcification.Calcification can also cause stenosis due to cuspal stiffening.Calcific deposits are usually localized to cuspal tissue (intrinsic calcification).There are strong risk factors and significant patient¿s clinical history (i.E.Hypertension, obesity, lipidoses, intermediate coronary syndrome, osteoarthritis, ckd stage iii and polymyalgia rheumatica, hypothyroidism) the 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.Valve-in-valve procedure performed.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 13385819
• Report Number: 3004478276-2022-00119
• Device Sequence Number: 16598635
• Product Code: LWR
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)160930
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2016
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 91 KG