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

Model Number	PVF-S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer will submit a follow-up report upon completion of production records review and investigation of the returned valve.
Event or Problem Description
The manufacturer was notified of the early explant of a perceval plus aortic heart valve, pvf-s.According to reports, the patient initially had a 19 mm magna ease valve implanted in 2011, which was replaced with the perceval valve on (b)(6) 2025, via upper hemisternotomy.The immediate postoperative echocardiogram showed good valve function with no leakage.However, a follow-up echo scan performed on (b)(6) 2025, revealed a paravalvular leak, aortic valve insufficiency, and valve's displacement was suspected.Due to the highly deteriorated patient conditions, an emergency reoperation was conducted on the same day.During the reoperation, the perceval valve was found to be completely intact and well-positioned, but a significant tear in the annulus was identified as the source of the paravalvular leak.The perceval valve was easily removed, the tear on annulus was repaired using prolene 4/0 sutures and a 19 mm edwards inspiris valve was implanted.Based on the medical assessment, the event was deemed unrelated to the perceval prosthesis or the implantation procedure.The most plausible cause, according to the medical judgment, was the patient¿s delicate anatomical structure encountered during the explantation of the re-stenosed magna ease valve.
Additional Manufacturer Narrative
Updated sections: b4, g3, g6, h2, h3, 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.The prosthesis was returned to the manufacturer, and it was received on october 30, 2025.The returned valve was received in the explant kit, inside the provided plastic jar without liquid.The returned prosthesis appeared in general good storage conditions and was still moist despite the lack of liquid in the jar.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The correct dimensions of the returned device were confirmed through the use of the appropriate tool.In order to attempt to reproduce the reported event, a replication of collapsing phases was performed using the returned valve pvf-s and a demo accessory kit.No problems were encountered in positioning and collapsing the returned valve.During the valve deployment and ballooning phase in the silicon aortic root (size 21), no problems were encountered.The valve positioning and sealing at the annulus level were guaranteed, and the prosthesis remained fixed within the annulus without observing significant anomalies.Inserting some water in the aortic root from the outflow side, and considering the static conditions of the test, no paravalvular leaks were observed during the simulation and the water level remained stable under the leaflets free edge.Based on the analyses carried out, a correlation between the reported issue and the quality of the returned device can be excluded.In addition, based on the medical assessment, the event was deemed unrelated to the perceval prosthesis or the implantation procedure.The reported paravalvular leak was attributed to a tear in the patient¿s annulus, which, based on the clinical judgment, resulted from the patient¿s fragile anatomical structure encountered during the explantation of the re-stenosed magna ease valve.

• 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: 23543547
• Report Number: 3004478276-2025-00183
• Device Sequence Number: 9683204
• Product Code: LWR
• UDI-Device Identifier: 08022057015365
• UDI-Public: (01)08022057015365(240)PVF-S(17)290524
• 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): 12/19/2025

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-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2025
• 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 Age: 69 YR
• Patient Sex: Female