MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS23

Device Problem Degraded (1153)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve and nitinol stent, model#: icv1209, 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 and its component have been manufactured and controlled in accordance with the specifications for a model#: icv1209 perceval heart valve at the time of manufacture and release.Since the device was not accessible for testing and further investigation on the device could not be performed, 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 perceval s valve.However, little clinical history was provided, and a definitive root cause cannot be stated at this time.It should be noted that structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.H3 other text : tavi performed.

Event Description

The manufacturer was informed that a patient who had a perceval valve size m implanted on (b)(6) 2018, went under tavi with medtronic evolute (fx-23) device on (b)(6) 2023 due to the valve failure.Based on the further information received, at the time of follow-up visit with the patient on (b)(6) 2023, patient was nyha iii, had mild aortic regurgitation, an aortic mean gradient of 16.8mmgh and an aortic valve area of 1.1cm squared.Left ventricular ejection fraction was 50%.There were issues with high blood pressure that was not controlled, mitral valve stenosis with a mean gradient of 6.7mmgh, some mitral regurgitation as well as some tricuspid valve regurgitation.Reportedly, patient was admitted to hospital on (b)(6) 2023 with a worsening condition.The echo stated that the aortic insufficiency was more significant and showed an aortic valve degeneration.On (b)(6) 2023, ejection fraction was 45%, lv function and aortic regurgitation was gotten worsen.As such, tavi was performed.As reported, surgeon mentioned that clinically patient seemed worse than the amount of svd from the echo, and that other issues with the mitral and tricuspid valve contributed to patient's condition as well.Reportedly, procedure was completed with no issues.The post procedure mean gradient for the tavi device was 19.4mmgh, with 1.3cm squared aortic valve area and no aortic regurgitation.On a 30-day follow-up, the patient was feeling better, was nyha i with an ef of 46%.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: 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 V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18165288
• MDR Text Key: 328480609
• Report Number: 3004478276-2023-00199
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)211027
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150011
• 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
• Report Date: 11/17/2023

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 Expiration Date: 10/27/2021
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2017
• 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 Sex: Female