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

Model Number	LXA21
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
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 st jude original in (b)(6) 2013 and upgrade to boston scientific in (b)(6) 2023 (st jude =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 13,917, 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.

• Brand Name: MITROFLOW LXA
• 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: 19225507
• Report Number: 3019892983-2024-01005
• Device Sequence Number: 8106070
• 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
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2024
• Report Date (Section F): 04/02/2024

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
• Distributor Facility Aware Date: 04/02/2024
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• 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: Death
• Patient Age: 76 YR
• Patient Sex: Male