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	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a perceval plus valve, pvf-m, was implanted with mics procedure.After de-clamped, pvl (mild) was noted, and the valve position was slightly adjusted.However, since moderate pvl was noted again after de-clamped, the valve was explanted.The annulus was re-sized, but size l could not go through.As such, the same valve was re-implanted.Mild pvl was noted after de-clamped, and the surgery was completed.The condition was better in the next morning though pvl was still noted.As further reported, no positioning difficulty was noted, and ballooning was performed according to the ifu.More than 60 minutes was added to the cross-clamp time and bypass time.The patient remained stable throughout the delay in procedure and patient¿s outcome was good.Based on the medical judgment, the size selection should have been correct (m white passed with slight resistance, l white failed to pass), and the placement position should also be fine.Reportedly, the annular shape was distorted with a significant difference between the major and minor diameters.
Additional Manufacturer Narrative
Manufacturer is retrieving and reviewing the production documents.A follow up report will be provided upon completion of this review and/or receipt of any further information.
Additional Manufacturer Narrative
Updated sections b4, g3, g6, h2, h6, h11.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.Since the device was not accessible for further testing, definitive root cause of the reported event cannot be established at this time.However, from the document review performed, no manufacturing deficiencies were noted.Based on the information available, the annular shape was distorted with a significant difference between the major and minor diameters.As such, it is possible that this distortion in the annulus may have contributed to the reported pvl leak, but this cannot ultimately be confirmed.Furthermore, it was reported that the device that was explanted, was reimplanted in the patient.It should be noted that per warning in the product ifu, " a removed perceval plus prosthesis must not be reimplanted, because its integrity is no longer ensured".

• 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 CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 23446055
• Report Number: 3004478276-2025-00180
• Device Sequence Number: 9040683
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)290517
• 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
• Report Date (Section B): 12/13/2025

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-M
• Device Catalogue Number: PVF-M
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2025
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male