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

Model Number	PVF-XL
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a perceval plus valve pvf-xl was implanted in a patient.When checking the valve on echo post implant, it appeared that one of the leaflets was not moving properly and was causing a leak.As further reported, the site confirmed that the surgeon implanted an xl and said everything looked fine until echo.Reportedly, it looked like one of the leaflets was not moving.As such, they went back on pump to adjust it but had the same issue.As such, the perceval valve was explant and a metronic avalus valve was implanted instead.
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.The device has been returned to the manufacturer and further investigation on the device is ongoing.A follow up report will be provided upon completion of investigation and/or receipt of any further information.
Additional Manufacturer Narrative
The valve was returned to the manufacturer.After decontamination, the valve was visually inspected without highlighting elements of non-conformity according to the specifications.On the other hand, a deformation on the leaflet #1 was observed.The hydrodynamic testing on the pvf-xl was conducted.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean aortic pressure of about 100 mmhg is 4.63 cm2, above the iso 5840 minimum requirement 1.7 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 6.7% and it is below the requirement of iso 5840 (rf% < 15%) for a prosthesis of equivalent tad.No anomalies were observed during valve opening and closing phase under both normotensive, and hypotensive conditions.This is further confirmed from the comparison with the images of the test carried out before the release of the product (steady flow test), which show no evidence of anomalous behavior, while a substantial correspondence can be observed in the morphology of the opening / closing leaflets.On the basis of the analyses carried out, the reported event cannot be explained by any factor intrinsic to the device involved since no regurgitations and opening/closure anomalies were observed during the functional test under hydrodynamic testing conditions per iso 5840:2021 requirements.Furthermore, from the document review performed, no device malfunction was noted.
Event or Problem Description
On (b)(6) 2024, a perceval plus valve pvf-xl was implanted in a patient.When checking the valve on echo post implant, it appeared that one of the leaflets was not moving properly and was causing a leak.As further reported, the site confirmed that the surgeon implanted an xl and said everything looked fine until echo.Reportedly, it looked like one of the leaflets was not moving.As such, they went back on pump to adjust it but had the same issue.As such, the perceval valve was explant and a metronic avalus valve was implanted instead.Based on the further information received, patient had an uneventful post op, it was an isolated surgery, patient's annulus was 27, no positioning difficulty was noted and there were no abnormal geometries in patient's annulus.Furthermore, about 30 minutes was added to the procedure as a result of this event but patient remained stable during the prolongation of surgery.

• 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: 20593618
• Report Number: 3004478276-2024-00182
• Device Sequence Number: 6528759
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)280614
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150011S013
• 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
• Report Date (Section B): 12/21/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2024
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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 Age: 87 YR
• Patient Sex: Male