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

Model Number	PVS25
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Codes	Pulmonary Edema (2020); Thrombocytopenia (4431); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A follow up report will be provided upon receipt of any further information or/and completion of investigation on the device.
Event or Problem Description
The perceval valve pvs25 was implanted on (b)(6) 2024.The patient was good after the surgery but on (b)(6) 2024, left heart failure and pulmonary edema was noted.Pvl was also found by echo.As such, the valve was explanted.
Additional Manufacturer Narrative
Device has been returned to the manufacturer.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The replication of collapsing phases was performed using the returned valve pvs-25/l and a demo accessory kit, in order to attempt to reproduce the reported event.No problems were encountered in the collapsing phase, and the replication has been completed with a good result.During the simulation of the valve deployment in silicon aortic root #25, no problems was encountered during the ballooning phase: the sealing at the annulus level was guaranteed; thus, the valve remained fixed within the annulus.Then, inserting some water in the aortic root from the outflow side, no paravalvular leaks was observed during both the simulation.Considering the static conditions of the test, the water level remained stable under the leaflets free edge.Since limited information was provided, the definitive root cause of the reported event cannot be established at this time.However, based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality.Furthermore, 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.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h6.The conclusion will remain the same.
Event or Problem Description
The perceval valve pvs25 was implanted on (b)(6) 2024.The patient was good after the surgery but on (b)(6) 2024, left heart failure and pulmonary edema was noted.Pvl was also found by echo.As such, the valve was explanted.Based on the further information received, after perceval was implanted, thrombocytopenia was noted (2.5 l) and platelet transfusion was done repeatedly.At the reoperation, thrombus in the left ventricle and damage to the aortic wall were found.The cause of the thrombus is unknown, and the damage to the aortic wall could have been caused by a perceval valve stent, but it could also have been caused by damage during removal of perceval.Reoperation was completed by implanting inspris valve, although bleeding control was difficult.Reportedly, patient passed away eventually at an unknown date.

• Brand Name: PERCEVAL 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: 19464109
• Report Number: 3004478276-2024-00138
• Device Sequence Number: 7870863
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)250210
• 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: 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,Followup
• Report Date (Section B): 05/20/2025

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: 02/10/2025
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2024
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 06/17/2024; 04/20/2025
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/16/2024; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 52 KG