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	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2025
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.The manufacturer is following up with the involved healthcare facility to retrieve additional information on the event and is awaiting the return of the prosthesis for evaluation.A follow-up report will be submitted upon receipt of any new details on the case or receipt/evaluation of the involved device.
Event or Problem Description
The manufacturer was notified of the early explant of a perceval plus size l, which occurred on (b)(6) 2025.Reportedly, the patient received the pvf-l valve in aortic position on (b)(6) 2023.Based on the available information, the patient is affected by myelodysplastic/myeloproliferative syndrome with sf3b1 and jak2 mutations and is on treatment with oncocarbide.On (b)(6) 2025, the valve was explanted and replaced by a bicarbon slimline valve.
Additional Manufacturer Narrative
Updated sections: b4, g3, g6, h2, h3, h6, h11 corrected sections: d9.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 valve was returned to the manufacturer and it was received in the explant kit.Examination of the valve revealed a deformed prosthesis due to intrinsic and vegetating calcifications in all leaflets.There was slightly pannus overgrowth on the inflow skirt of the valve.X- rays of the subject valve showed large intrinsic calcifications in all leaflets.All the leaflets were almost stiff due to intrinsic and vegetating calcifications.Scars and/or mesothelial delaminations were visible where intrinsic calcifications became extrinsic.Fibrous pannus depositions were visible on the crown, on all sinusal struts near the skirt and along almost all adherent margins.Two of the leaflets showed small thrombus deposits.Histological analyses were performed on samples taken from leaflets a and b.In leaflets a and b, alizarin red s stain showed that the pericardium was thicker than normal because of large intrinsic and-or vegetating calcifications.A pericardial fold was detected on leaflet b.In leaflets a and b, hematoxylin and eosin stain showed that the collagen bundles were disrupted, defibrated and homogenated.Red blood cells were visible on leaflets a and b.Degenerated inflammatory cells were present on the thrombus that is present on leaflet b.Thrombus depositions were visible on the mediastinic surface of leaflet a and on both surfaces of leaflet b.Pericardial delaminations were detected on leaflets a and b.Bacteria were not detected with the gram stain.In conclusion, as reported in the scientific literature, structural dysfunction is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.Calcification can also cause stenosis due to cuspal stiffening.Calcific deposits are usually localized to cuspal tissue (intrinsic calcification).Histological analysis showed some thrombus depositions.It is possible that the patient¿s clinical history and risk factors (myelodysplastic/myeloproliferative syndrome) may have contributed to the structural valve deterioration observed in this perceval plus valve.However since little information has been provided despite the follow-up attempts, no definite root cause for the reported event can be identified.Ultimately, it should be noted that structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.

• 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 CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 23935101
• Report Number: 3004478276-2025-00197
• Device Sequence Number: 9627385
• Product Code: LWR
• UDI-Device Identifier: 08022057015389
• UDI-Public: (01)08022057015389(240)PVF-L(17)260925
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/20/2026

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: 09/25/2026
• Device Model Number: PVF-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2022
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 75 KG