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

Model Number	PVF-S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a perceval plus valve pvf-s was implanted in a patient.Pci was also performed, but they were unable to cannulate coronary artery.Echocardiography confirmed that the perceval plus valve popped up (i.E., inflow ring popped up to the level of the coronary artery).Pvl did not get worsen.Reportedly, the procedure was problematic.Transcatheter aortic valve replacement (tavr) with transfemoral approach (ta) approach was performed.The perceval plus valve was pulled up into the ascending aorta with a snare cuff and a tavi valve was implanted.Subsequently, pci was performed without any problems.The remaining perceval plus valve is now fixed to some extent and there is no hemodynamic problem.
Additional Manufacturer Narrative
Manufacturer is retrieving and reviewing the manufacturing documents of the device.A follow-up report will be submitted upon the completion of the review and/or availability of new, relevant details.
Additional Manufacturer Narrative
Updated sections b4, g3, g6, h2, h6.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.Manufacturer is retrieving additional details from the field.A follow-up report will be provided upon availability of new, relevant details.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6.Manufacturer attempted to follow up with the site, but no further information has yet been received.Since limited information is available and the device was accessible for further investigation, the definitive root cause of the reported event cannot be established.However, from the document review, no manufacturing deficiencies were noted.Should further information be available in the future, a follow up report will be provided.

• 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: 22741965
• Report Number: 3004478276-2025-00163
• Device Sequence Number: 8385880
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)281220
• 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,Followup
• Report Date (Section B): 01/14/2026

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-S
• Device Catalogue Number: PVF-S
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 01/14/2026
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/29/2025; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 45 KG