MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-M
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The manufacturer was informed of a failure to implant a perceval plus valve pvf-m occurred on (b)(6) 2024.Reportedly the prosthesis was attempted to be implanted in a patient with a bi-cuspid type 1 native aortic valve.However, due to severe central leak detected at the intra-operative echo check, the device was explanted and replaced with a conventional valve without complications.As further reported, the event caused a delay in surgical time of about 25-30 minutes with no impact on the patient.
Additional Manufacturer Narrative
The device implicated in the reported incident was returned to the manufacturer for analysis and was received in a plastic jar without storage liquid, though still wet.Following decontamination, the valve underwent a visual inspection, which did not reveal any non-conformities according to the specifications.The height of each leaflet was verified using a specific tool, confirming conformity.Dimensional analysis, performed with a dedicated gauge on both the valve inflow skirt and the sinusoidal structures, confirmed the correct dimensions of the returned device.Subsequently, hydrodynamic testing was conducted on the pvf-m prosthesis.The effective orifice area (eoa) at 70 bpm, with a cardiac output of 5.0 l/min and a mean aortic pressure of approximately 100 mmhg, was 2.94 cm², exceeding the iso 5840 minimum requirement of 1.25 cm².For a cardiac output of 5.0 l/min and a mean aortic pressure of approximately 100 mmhg, the regurgitant fraction was 2.9%, which is below the iso 5840 requirement (rf% < 10%) for a prosthesis of equivalent tad.No anomalies were observed during the valve's opening and closing phases under both normotensive and hypotensive conditions.This was further corroborated by reviewing images from the test conducted prior to the prosthesis's release (steady flow test), which showed no evidence of anomalous behavior and a substantial correspondence in the morphology of the opening and closing leaflets with that observed during the hydrodynamic testing of the returned device.Based on the analysis performed, the reported event cannot be attributed to any intrinsic factor within the involved device, as no coaptation anomalies were observed during the functional test under hydrodynamic testing conditions as per iso 5840:2021.Furthermore, the visual inspection and dimensional analyses of the returned prosthesis confirmed the absence of pre-existing defects.It is possible that the reported incomplete coaptation was due to unintended undersizing or mispositioning of the perceval prosthesis, given the challenging anatomy of the native aortic valve (bicuspid type 1).However, this cannot be definitively confirmed based on the available information.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 20756064
• Report Number: 3005687633-2024-00121
• Device Sequence Number: 8671533
• Product Code: LWR
• UDI-Device Identifier: 08022057015372
• UDI-Public: (01)08022057015372(240)PVF-M(17)280417
• 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: 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): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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: Female