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

Model Number PVS25

Device Problem Perivalvular Leak (1457)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device has been received, investigation is ongoing.

Event Description

The manufacturer was informed that on (b)(6) 2023, a perceval valve size 25 was implanted in a patient through full sternotomy and isolated procedure.Reportedly, it was found that the patient had a quadrilobation deformity of the aortic valve with severe regurgitation, and severe perivalvular leakage occurred post-procedure.As such, the device was explanted and replaced with a non-corcym biological valve.Based on the further information received, no mispositioning or mis-sizing were identified, and annulus was measured as 25.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h3, h6.The manufacturing and material records for the perceval heart valve and stent, model #icv1210, 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 has been manufactured and controlled in accordance with the specifications for a (model # icv1210) perceval heart valve at the time of manufacture and release.The device has been returned to the manufacturer.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The replication of collapsing phases was performed using the returned valve pvs 25/l and a demo accessory kit, in order to attempt to reproduce the reported event.No problems were encountered in the collapsing phase, and the replication has been completed without problem.No problems were encountered during the deployment in silicon aortic roots #25, and the ballooning phase, and the sealing at the annulus level is guaranteed as visible in attached pictures; thus, the valve remained fixed within the annulus.Then, inserting some water in the aortic roots from the outflow side, no paravalvular leaks were observed during the simulation.Considering the static conditions of the test, the water level remained stable under the leaflets free edge.Based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality.Furthermore, form the document review performed, no manufacturing deficiencies were noted.From the information provided, patient had a ¿quadrilobation deformity¿.As such, it is possible that patient anatomy and condition has contributed to the claimed behavior of the prosthesis.

• Brand Name: PERCEVAL SUTURELSS 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: 18414683
• MDR Text Key: 331581177
• Report Number: 3004478276-2023-00220
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 0089628000436
• UDI-Public: (01)0089628000436(240)ICV210(17)251105
• 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: 02/08/2024

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
• Device Operator: Health Professional
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2021
• 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