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

Model Number PVS25

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve and nitinol stent, model #icv1210, 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 and component satisfied all material, visual, and performance standards required for a (model #icv1210) perceval heart valve at the time of manufacture and release.

Event Description

The manufacturer was informed of the following event through patient tracking department.Based on the information received from the patient implant forms, a perceval valve size 25 was implanted in the patient on (b)(6) 2017.On (b)(6) 2022, a carbomedics top hat aortic mechanical heart valve was implanted in the patient in the same position.No further details are presently available and no allegation of a device malfunction nor serious injury on the patient has been received from the site regarding this event.

Manufacturer Narrative

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.Furthermore, during the document review, no device deficiencies were identified.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.

Event Description

The manufacturer was informed of the following event through patient tracking department.Based on the information received from the patient implant forms, a perceval valve size 25 was implanted in the patient on (b)(6) 2017.On (b)(6) 2022, a carbomedics top hat aortic mechanical heart valve was implanted in the patient in the same position.No further details are presently available and no allegation of a device malfunction nor serious injury on the patient has been received from the site regarding this event.Based on the additional information received, the valve was explanted due to svd, patient remained stable through the surgery and had a good outcome.

• 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
• 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: 16018508
• MDR Text Key: 305871930
• Report Number: 3004478276-2022-00215
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/03/2023

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: 01/08/2021
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female