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

Model Number PVS23

Device Problem Perivalvular Leak (1457)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/25/2024

Event Type  Injury  

Event Description

The perceval valve pvs23 was implanted on (b)(6) 2024 with mics (rat).Pvl was mild.On 25 january 2024, pvl was noted and judged to be more than moderate with tte.As such, the re-operation was done with median sternotomy.Ballooning was done for perceval, but it did not work so the valve was explanted and replaced with inspris 21mm.Right after the surgery, the blood platelet was getting low but improved to 50,000.Before the re-operation, blood platelet was 13,000.No transfusion or dialysis has been done so far.

Manufacturer Narrative

The device was 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 organic material / coagulated blood, found on the prosthesis, can be consistent with the incoming steps of the process of endothelization between the annulus and the pericardial surface along the fourteen (14) days of implanting time.From the visual analysis of the aforementioned residues, it is not possible to establish with certainty a correlation between their distribution and a specific area in which the reported pvl was hypothetically located.The replication of collapsing phases was performed using the returned valve pvs 23/m 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 with a good result.During the simulation of the valve deployment in silicon aortic root #23, no problems were encountered during the ballooning phase: 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 root from the outflow side, no paravalvular leaks were observed during the simulations.Considering the static conditions of the test and despite the residual of organic material on the external surface of the pericardial skirt, the water level remained stable under the leaflets free edge.Based on the information available, the definitive root cause of the reported event cannot be established at this time.However, based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device.Furthermore, from the document review performed, no manufacturing deficiencies were noted.Should further information be received in the future, a follow up report will be provided.

• 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: 18744489
• MDR Text Key: 335812181
• Report Number: 3004478276-2024-00115
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2023
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 68 KG