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

Model Number	LXA21
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Mitral Valve Stenosis (1965)
Date of Event	03/08/2024
Type of Reportable Event	Death
Event or Problem Description
Manufacturer was informed of the following event through patient tracking department.Reportedly, a patient who had a mitroflow valve lxa21 implanted on (b)(6) 2013, was under evaluation for tavr due to aortic stenosis.Based on the further information received, patient had a pmh of bioprothtetic savr and mitral annuloplasty ring in 2013.There was persistent afib with cha2ds2-vasc score of 4, vt, biv icd (b)(6) original in (b)(6) 2013 and upgrade to boston scientific in (b)(6) 2023 ((b)(6) =lead to rv remains).Reportedly, patient was admitted to hospital on (b)(6) 2024 with increasing bilateral le swelling and pain to legs for a couple days.Patient was found to be in acute chronic decompensated heart failure with bnp (b)(4), neg trop of 32, creat 2.2 and lactic acid 1.2.Patient then was admitted to the icu.Patient's tsh was notably high and free t3/t4 was low.Patient was seen by endocrine for a differential of myxedema coma and adrenal insufficiency and given iv synthroid and hydrocortisone.Patient then remained on pressors and was transferred to ifh with mixed cardiogenic/metabolic shock and was found to have severe stenosis of both aortic and mitral valves.As such, due to the complex medical history and redo status, and high-risk patient for redo savr; patient went under evaluate for possible tavr +/-tmvr.However, no tavr was ultimately performed since patient passed away on (b)(6) 2024.Based on the further information received, patient had increased fatigue and increased bilat leg swelling prior to admission.Patient denies sob, cp, palpitations or dizziness.Patient's assessment was reported as follow: aortic bioprosthesis dysfunction; moderate to severe mr mixed with ms s/p mitral annuloplasty 2013; acute on chronic hfref; aki on ckd ill; leg cellulitis; severe hypothyroidism; vt s/p aicd; nicm with lvef 25% s/p biv-icd upgrade 2023; ascending aorta aneurysm; anemia; ulcerative colitis flare up; and rheumatic arthritis.
Additional Manufacturer Narrative
The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.Based on the information available, the definitive root cause of the reported event cannot be established at this time.However, from the document review performed, no manufacturing deficiencies were noted.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).It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this mitroflow valve.However, little clinical history was provided, and this cannot ultimately be confirmed.It should be noted that structural valve deterioration is listed as a possible adverse event in the mitroflow ifu.Furthermore, since the exact cause of patient death was not reported, the definitive root cause of the reported event cannot be confirmed.

• Brand Name: MITROFLOW LXA
• Common Device Name: 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: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 19225518
• Report Number: 3004478276-2024-00133
• Device Sequence Number: 12788715
• Product Code: LWR
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)180430
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 04/30/2018
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2013
• 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: Death
• Patient Age: 76 YR
• Patient Sex: Male