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

Model Number	PVF-M
Medical Device Problem Codes	Perivalvular Leak (1457); Device Handling Problem (3265)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing and material records for the valve and nitinol stent involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis and its component satisfied all required material, visual, and performance standards at the time of manufacture and release.The manufacturer is following up with the site to retrieve additional information on the event and the device involved and will submit a follow up report upon receipt of additional information or completion of the investigation on the returned prosthesis.H3 other text : device has been received and undergoing analysis.
Event or Problem Description
The manufacturer was informed of an intra-operative explant of a perceval plus sutureless aortic valve size m.Reportedly, the implanting surgeon observed a possible paravalvular leak and replaced the prosthesis with another valve of the same model and size.According to the information received, the patient was not affected by the prolongation of surgical time.
Event or Problem Description
The manufacturer was informed of an intra-operative explant of a perceval plus sutureless aortic valve size m.Reportedly, the implanting surgeon observed a possible paravalvular leak and replaced the prosthesis with another valve of the same model and size.According to the information received, the patient was not affected by the prolongation of surgical time.As per additional information received on may 15th 2024, the involved surgeon clarified that the issue was caused by an error made by the operator while collapsing the perceval valve, which led to an incorrect deployment of the prosthesis.The manufacturer received confirmation that the relyon accessory kit used to collapse the prosthesis performed as expected.
Additional Manufacturer Narrative
The perceval valve involved in the reported event was returned to the manufacturer for analysis and appeared in good storage conditions.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The correct dimensions of the returned device were confirmed through the use of the appropriate tool.In order to attempt to reproduce the reported event, a replication of collapsing phases was performed using the returned valve pvf-m and a demo accessory kit.No problems were encountered in positioning and collapsing the returned valve.During the valve deployment and ballooning phase in the silicon aortic root (size 23), no problems were encountered.The valve positioning and sealing at the annulus level were guaranteed, and the prosthesis remained fixed within the annulus without observing significant anomalies.Inserting some water in the aortic root from the outflow side, and considering the static conditions of the test, no paravalvular leaks were observed during the simulation and 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.The review of production records confirmed that the prosthesis met all the specifications at the time of manufacture and release.The visual inspection performed on the returned valve did not highlight pre-existing defects and the dimensional verification confirmed that the returned pvf-m valve meets the specifications.The deployment simulation performed did not highlight anomalies at the annulus level.Furthermore, the static leak test, although not entirely representative of physiological conditions, did not highlight any perivalvular leaks.According to the additional information received, an error was made by the operator while collapsing the perceval valve, which led to an incorrect deployment with consequent malpositioning of the prosthesis and can be reasonably attributed as the root cause of the reported event.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: 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, bc 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: 19124369
• Report Number: 3004478276-2024-00129
• Device Sequence Number: 7621381
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)271007
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150011/S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown