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

Model Number PVS23

Device Problem Perivalvular Leak (1457)

Patient Problems Low Blood Pressure/ Hypotension (1914); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/12/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a perceval valve size m (this case) was implanted in the patient whose native valve was bicuspid type 1.After implantation and de-clamp, mild pvl in non-coronary part was noted.Reportedly, surgical site was closed but was re-opened because blood pressure went low.As such, the valve was explanted, and another perceval valve size l was implanted instead (b)(4).

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h6.A follow up report will be provided upon receipt of further information or competition of any investigation.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h3, h6.The manufacturer attempted to retrieve further information regarding this event, but no further information was provided despite manufacturer's multiple attempts of follow up.The manufacturing and material records for the perceval heart valve and stent, model # icv1209-jp, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by a manufacture¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a (model # icv1209-jp) perceval heart valve at the time of manufacture and release.The valve 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 replication of collapsing phases was performed using the returned valve pvs 23/m and a demo accessory kit.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 deformation observed at the inflow side level, the water level remained stable under the leaflets free edge.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device.Furthermore, from the document review, no manufacturing deficiencies were noted.The deployment simulation, performed on the returned valve, did not highlight anomalies and the valve resulted globally well deployed and fixed in stable way with no paravalvular leaks.As such, it is possible to exclude the relationship between the reported issue and the returned device quality.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: 17295049
• MDR Text Key: 318780433
• Report Number: 3004478276-2023-00160
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)250209
• 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,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• 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: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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: Male