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

Model Number	LXA23
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Stroke/CVA (1770); Fatigue (1849)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
The manufacturer was informed on this event through the patient tracking department.Based on the information provided, a patient was scheduled to undergo a tavr on (b)(6) or (b)(6) 2022.The patient received a mitroflow valve lxa23 on (b)(6) 2012 in aortic position.The day before the tavr procedure, the patient had a massive stoke.The patient survived, but is no longer suitable for the procedure.The patient had valve failure due to stenosis.The patient was transferred to a hospice care.
Event or Problem Description
The manufacturer was informed on this event through the patient tracking department.Based on the information provided, a patient was scheduled to undergo a tavr on (b)(6), 2022.The patient received a mitroflow valve lxa23 on 01 may 2012 in aortic position.The day before the tavr procedure, the patient had a massive stoke.The patient survived, but is no longer suitable for the procedure.The patient had valve failure due to stenosis.The patient was transferred to a hospice care.Based on the patient report received, patient had cardiac debility due to tavr 6/6/22 with bioprosthetic aortic valve failure and aortic insufficiency 6/622, 5/23/22, 5/13/22 by lhc.The patient has history of aos/aor s/p biopeosthetic avr in 2012; acute on chronic grade 2 early grade 3 distolic dysfunction; afib.Multiple lhc demonstrated failure of prosthetic valve and need replacement.However due to patient's anatomy and need for basilica (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) during/after tavr, initial procedure scheduled on (b)(6) 2022 was rescheduled for (b)(6) 2022.However, the patient's hospital course was further complicated by acute encephalopathy 6/6/22 and code white 5/23/22 which as mentioned was improved with narcan, likely it was toxic metabolic encephalopathy, vertebral artery thrombosis.Patient also had rectal bleeding, epistaxis on 4 june 2022.Patient had acute hypoxic hypercapnic respiratory failure on 9 may 2022 with sever dyspnea.As reported, the tavr was eventually performed on 6 june 2022.Patient was transferred to rehab on 11 june 2022 in stable condition.Based on the information received, the creatinine slightly elevated at 1.46 taken into account that patient have ckd stage iii, but no other acute issues has been noted.Reportedly, patient's rehab course was relatively remarkable with good progress and patient was discharged home on (b)(6) 2022.As reported, in addition to aortic stenosis and regurgitation, patient also has history of ckd, iiin, iild, iiipli, iia, gib.As reported in the problem list, patient has valvular heart disease, acute respiratory insufficiency, renal insufficiency, hyperlipidemia, anemia, hypertension, valve stenosis, chf, hypertensive heart disease, acute pulmonary embolism, acute on chronic diastolic heart failure, and hypertensive heart and chronic kidney failure with heart failure and stage 1 through stage 4 chronic kidney failure, or unspecified chronic kidney disease.Patient's medications are reported as follow: hydralazine hcl, vitamin d3, vitamin c, feosol, norvasc, ipratropium, nitroglycerin sl, apixaban, aspirin, furosemide.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa23, s/n # (b)(6), 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 lxa23 mitroflow aortic pericardial heart valve at the time of manufacture and release.Since the device was not explanted and tavr was performed, further investigation on the device cannot be performed.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 (i.E., hyperlipidemia, hypertension, hypertensive chronic kidney failure, stage 1 through stage 4 chronic kidney failure, and renal insufficiency) may have contributed to the structural valve deterioration observed in this perceval s valve.It should be noted that structural valve deterioration and thromboembolism (stroke) are listed as a possible adverse event in the mitroflow valve ifu.The event is therefore a known inherent risk of the device.Should further information be received in the future, the manufacturer will re-open the case and take further actions as applicable.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 14791415
• Report Number: 3004478276-2022-00159
• Device Sequence Number: 17669294
• Product Code: LWR
• UDI-Device Identifier: 00896208000115
• UDI-Public: (01)00896208000115(240)LXA23(17)161130
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 08/04/2022

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 Model Number: LXA23
• Device Catalogue Number: LXA23
• 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: 05/30/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2011
• 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: Other; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 96 KG