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

Model Number	PVF-M
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perceval plus valve, pvf-m was used for a double valve (mitral and aortic) procedure on (b)(6) 2025.The aorta was reported as porcelain and heavily calcified.Perceval was used to help get the patient out of the or as patient was not tolerating the surgery well.A medium perceval was implanted, and it was found that there was a paravalvular leak following the implant.Following surgery, a balloon was used to open the valve in the cath lab, which helped a little but was not enough to stop the leak.As such, patient was brought back for a surgery and the perceval valve was explanted and complete aortic root replacement was performed.It is reported that the patient is still recovering from this procedure at this time.Based on the medical judgment received, the issue most likely occurred due to the amount of calcium and no issue with the perceval valve was reported.
Event or Problem Description
It was reported that a perceval plus valve, pvf-m was used for a double valve (mitral and aortic) procedure on (b)(6) 2025.The aorta was reported as porcelain and heavily calcified.Perceval was used to help get the patient out of the or as patient was not tolerating the surgery well.A medium perceval was implanted, and it was found that there was a paravalvular leak following the implant.Following surgery, a balloon was used to open the valve in the cath lab, which helped a little but was not enough to stop the leak.As such, patient was brought back for a surgery and the perceval valve was explanted and complete aortic root replacement was performed.It is reported that the patient is still recovering from this procedure at this time.Based on the medical judgment received, the issue most likely occurred due to the amount of calcium and no issue with the perceval valve was reported.Based on the further information received, the surgery was full sternotomy, and the perceval implant occurred after mitral valve replacement and ballooning was performed.Manufacturer was informed that no further information will be provided.
Additional Manufacturer Narrative
Patient identifier in section a1 was mistakenly included as (b)(6) in the initial report instead of (b)(6) which is now updated.The manufacturing and material records for the device 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 satisfied all required material, visual, and performance standards at the time of manufacture and release.Based on the medical judgment received, the issue most likely occurred due to the amount of calcium and no issue with the perceval valve was reported.Furthermore, from the document review performed, no manufacturing deficiencies were noted.As such, based on the medical judgement, the cause of the event was related to patient condition.

• 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
• 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: 21339508
• Report Number: 3004478276-2025-00119
• Device Sequence Number: 8598532
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)260616
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/13/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2026
• Device Model Number: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: No
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2022
• 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: Female