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

Model Number	PVS21
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	01/28/2026
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 device was returned to the manufacturer.The stent and the skirt were covered by fibrous pannus that on the inflow side protruded 2-3mm into the lumen, narrowing the annulus, and caused a low degree of stenosis.The tops of posts 1 and 3 were covered by fibrous pannus that grew on the free edges of leaflets contributes to stenosis.Reddish areas due to coagulated blood entrapment were present on almost all surfaces.The free edge of all leaflets was outflow bent near the posts due to fibrous pannus and so caused a low degree of insufficiency.All the leaflets were pliable.Small intrinsic calcifications are present in all leaflets near the struts.The mesothelial surfaces of all leaflets were locally wrinkled.Leaflet a: whitish areas due to tissue alterations were detected near post 2.Histological analyses were performed on samples taken from leaflets a and c.In leaflets a and c, alizarin red s stain showed that the pericardium was thicker than normal because of intrinsic calcifications.In leaflets a and c, hematoxylin and eosin stain showed that the collagen bundles were locally disrupted, defibrated and homogenated.Red blood cells were visible on leaflets a and c.Fibrous pannus depositions were visible on both surfaces of leaflets a and c.Pericardial delaminations were detected on leaflets a and c.Bacteria were not detected with the gram stain.Based on the limited information available, the definitive root cause of the event cannot be established at this time.However, from the document review performed, no manufacturing deficiencies were noted.As reported in the scientific literature, structural valve deterioration 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).It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this perceval s valve.However, little clinical history was provided, and a definitive root cause cannot be stated at this time.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.
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 device was retrieved and returned to the manufacturer for analysis.Device evaluation is currently ongoing.Based on the dimensional comparison between the explanted perceval valve and the mechanical prosthesis ultimately implanted in the patient, it can be reasonably suspected that the perceval valve was too big for the patient's annulus.A follow-up report will be submitted upon receipt of any new information or at the completion of the investigation.
Event or Problem Description
The manufacturer was notified of a re-do surgery involving a perceval s sutureless aortic heart valve, size s.The following provides a summary of all information currently available to the manufacturer from the facility.On (b)(6) 2021, a perceval valve pvs21 was successfully implanted.The prosthesis was explanted on (b)(6) 2026 due to structural valve deterioration.It was reported as a calcified valve with one leaflet frozen.The surgeon removed the perceval prosthesis by cutting it and implanted a carbomedics top hat mechanical valve size 21 as a replacement.The patient is currently recovering.

• 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: 24440573
• Report Number: 3004478276-2026-00120
• Device Sequence Number: 10220635
• Product Code: LWR
• UDI-Device Identifier: 08022057014696
• UDI-Public: (01)08022057014696(240)ICV1208(17)240318
• 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: 2026
• 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): 04/02/2026

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: 03/18/2024
• Device Model Number: PVS21
• Device Catalogue Number: PVS21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 102 KG