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

Model Number	PVS23
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	09/24/2025
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.A follow-up report will be submitted upon completion of the investigation on the returned device.
Event or Problem Description
The manufacturer was notified of the explantation of a perceval s aortic heart valve size 23, pvs23.Reportedly, the prosthesis had been implanted on (b)(6) 2021.Recent transthoracic and transesophageal echocardiography (tee) confirmed severe bioprosthetic valve stenosis due to early degeneration, with a mean gradient of 60 mmhg.The evaluation revealed very severe aortic stenosis, with a mean transvalvular gradient of 44 mmhg and an aortic valve area of 0.56 cm² (indexed at 0.27 cm²/m²).The early degeneration of the prosthesis led to two episodes of syncope.Consequently, the perceval valve was explanted and replaced with a 21 mm saint jude valve on (b)(6) 2025.According to the information received, the patient's risk factors include diabetes, with a history of hospitalization in february 2021 for diabetic hyperglycemic decompensation accompanied by malaise.Obesity has been reported as an additional medical condition.
Additional Manufacturer Narrative
Updated sections: b4, g3, g6, h2, h3, h6, and 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 returned valve was received in the explant kit¿s plastic jar filled with unknown liquid.Upon initial inspection, the prosthesis exhibited pannus formation on both the inflow and outflow sides.Pannus was observed around the posts, along the radial internal and external pericardial skirt, and on the outflow stent.The leaflets¿ edges appeared extremely stiff with markedly reduced mobility, showing visible calcification.The pericardium of the section of the skirt and ceiling collar around the third post appeared in a darker black colour, different from the rest, reasonably been caused by a not adequate storage condition.Following decontamination, the valve underwent radiographic examination, which revealed extensive calcification throughout the prosthesis.Both extrinsic and intrinsic calcifications were observed on the leaflets, with a notably dense accumulation at the commissures and on the free edge on the leaflets.Despite severe deterioration, a dimensional verification was possible, which confirmed the correct nominal dimensions.Based on the manufacturer¿s experience and on the clinical information provided, it is reasonable to conclude that the patient¿s medical history, particularly diabetes, likely contributed to the structural deterioration observed in the returned valve.Diabetes is well recognized in literature as a risk factor for accelerated bioprosthetic valve degeneration.

• Brand Name: PERCEVAL 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: 23543807
• Report Number: 3004478276-2025-00184
• Device Sequence Number: 9683729
• Product Code: LWR
• UDI-Device Identifier: 08022057014702
• UDI-Public: (01)08022057014702(240)ICV1209(17)240212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/24/2025

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 Expiration Date: 02/12/2024
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2020
• 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: 61 YR
• Patient Sex: Female