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

Model Number	PVF-L
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is following up with the field to retrieve additional details on the event and the device involved.Furthermore, the manufacturing documents are getting retrieved and reviewed and the investigation on the device is ongoing.A follow up report will be provided upon availability of relevant details and/or completion of review and investigation.
Event or Problem Description
On (b)(6) 2025, after concomitant procedure (tap, maze and map), the perceval plus valve pvf-l was implanted in a patient through avr.After de-clamped, a mild pvl was noted.They waited to see the condition for 30 minutes, but pvl remained the same.As such, the valve was explanted and replaced with inspiris valve 25mm instead.No further information has been received from the site at this time.
Additional Manufacturer Narrative
Updated sections b4, g3, g6, h2, h3, h6.Based on the performed analysis, the reported event cannot be attributed to any intrinsic factors of the involved device, as no paravalvular leaks were observed during the simulation of the static leak test, confirming the stability of the positioning and sealing performance.Furthermore, from the document review performed, 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.No paravalvular leaks were observed during the simulation of the static leak test as further confirmation of the stability of the positioning and sealing performance.Based on the manufacturer¿s experience, it is reasonable to assume that the reported complications may be linked to a possible malpositioning of the device, likely due to the complexity of the procedure, which involved four simultaneous interventions.However, since limited information is available this cannot ultimately be confirmed.

• 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: 22903530
• Report Number: 3004478276-2025-00169
• Device Sequence Number: 18120391
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)290516
• 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
• Device Explanted 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): 10/10/2025

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 Model Number: PVF-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• 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 Age: 69 YR
• Patient Sex: Male