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

Model Number	PVF-XL
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
In a redo case following tavi, perceval plus valve pvf-xl was used on (b)(6) 2025.However, following bypass removal, pvl occurred, necessitating conversion to a conventional valve instead.No further information has yet been received from the site at this time.
Additional Manufacturer Narrative
Manufacturer is retrieving further information from the facility, and will submit follow-up report upon availability of new, relevant details.
Additional Manufacturer Narrative
Updated sections b4, b5, d4, g3, g6, h2, h4, h6, h11 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.Since the device was not returned for further investigation and limited information is available, the definitive root cause of the reported event cannot be established at this time.However, 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.
Event or Problem Description
The manufacturer was notified of a failure to implant involving a perceval plus prosthesis.Reportedly, in a redo case following tavi, perceval plus valve pvf-xl was used on (b)(6) 2025.However, following bypass removal, pvl occurred, necessitating conversion to a conventional valve instead.Based on the further information received, the surgical approach was a full sternotomy with no concomitant procedure.The native valve was stenotic.Ballooning was performed according to the ifu.Approximately 30 minutes was added to the cross-clamp time and bypass time.The patient remained stable throughout the delay in procedure.The patient¿s impact and outcome were reported as improving and progressing well.There were no reported abnormal geometries in the patient's annulus, no device malpositioning or missizing identified.No positioning difficulty was noted.

• 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: 23889316
• Report Number: 3004478276-2025-00195
• Device Sequence Number: 9622827
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)280714
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• 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): 02/06/2026

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-XL
• Device Catalogue Number: PVF-XL
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2024
• 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