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

Model Number	PVF-L
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/19/2025
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.Manufacturer is performing the investigation on the returned device.A follow up report will be provided upon completion of this investigation and/or receipt of any further information.
Event or Problem Description
On (b)(6) 2025, during an avr case, the patient's annulus was assessed using an annulus sizer and a perceval plus valve size l was implanted in the patient.However, postoperative echocardiography revealed significant pvl, necessitating explantation of the perceval valve.The procedure was then completed using a 23mm conventional valve from another manufacturer.Reportedly, it was an isolated mics surgery, patient's annulus was around 23 mm, patient remained stable through the surgery, and patient's outcome was good.As reported, no mis-sizing nor positioning difficulty was noted and there was no abnormal geometry in patient's anatomy.No further information is available at this time.
Additional Manufacturer Narrative
Updated sections b4, g3, g6, h2, h3, h6.Review of the data filed in the device history record of the returned perceval plus heart valve sn (b)(6), confirmed that the valve satisfied all material, dimensional, and performance standards required for a perceval plus heart valve prosthesis pvf-l at the time of manufacture and release.The device was returned to the manufacturer for investigation.The visual inspection performed on the returned prosthesis confirmed the absence of pre-existing defects.The deployment simulation, performed on the returned valve, did not reveal any anomalies.The prosthesis appeared to be globally well deployed and stably fixed.No paravalvular leaks were observed during the static leak test, further confirming the stability of the positioning and sealing performance.Based on the analyses carried out, a correlation between the reported issue and the quality of the returned device can be excluded.As none of the reported issues were reproducible during the investigation, it was not possible to determine a definitive root cause.Further, no deficits were noted during the manufacturing documents review.However, based on the manufacturer¿s experience, the reported complications may be related to a possible malpositioning of the device, likely influenced by the complexity of the mics procedure.

• 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
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino saluggia vercelli; saluggia, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 23092027
• Report Number: 3005687633-2025-00128
• Device Sequence Number: 15876424
• Product Code: LWR
• UDI-Device Identifier: 08022057015389
• UDI-Public: (01)08022057015389(240)PVF-L(17)290308
• 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
• 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): 10/24/2025

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 Model Number: PVF-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2025
• 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