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	11/25/2025
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 explanted device was returned to the manufacturer.A follow-up report will be submitted upon completion of the device investigation.
Event or Problem Description
The manufacturer was notified of the early explant of a perceval s valve in size m pvs23.The prosthesis had reportedly been implanted on (b)(6) 2022, in the aortic position.According to the information provided, the valve later developed stenosis with a suspected endocarditis, leading to its removal on (b)(6) 2025.It was subsequently replaced with an avalus no.21 biological aortic valve.Further details from the site indicated that the perceval valve functioned properly from implantation until 2025, when the patient began experiencing discomfort.Additional information confirmed that there were no positioning difficulties during the 2022 implantation, nor any issues related to malposition or incorrect sizing.The native valve was reportedly bicuspid.
Event or Problem Description
The manufacturer was notified of the early explant of a perceval s valve in size m pvs23.The prosthesis had reportedly been implanted on (b)(6) 2022, in the aortic position.According to the information provided, the valve later developed stenosis with a suspected endocarditis, leading to its removal on (b)(6) 2025.It was subsequently replaced with an avalus no.21 biological aortic valve.Further details from the site indicated that the perceval valve functioned properly from implantation until (b)(6) 2025, when the patient began experiencing discomfort.The patient was then hospitalized on (b)(6) 2025 deu to severe dyspnea.Echocardiography confirmed stenosis of the prosthesis (peak gradient 97/42 mm hg, vmax 4.9 m/s) and mild ar (1 +), ef 50%.Additional information confirmed that there were no positioning difficulties during the 2022 implantation, nor any issues related to malposition or incorrect sizing.The native valve was reportedly bicuspid.The patient's medical history includes hypertension, dyslipidemia, family history of cardiovascular disease, diabetes mellitus.
Additional Manufacturer Narrative
Updated sections b4, b5, 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.Valve examination showed a deformed prosthesis with widespread intrinsic and vegetative calcifications affecting all leaflets, as confirmed with the x-ray imaging.Significant pannus overgrowth was present on the inflow skirt and extended onto the stent, protruding into the lumen and contributing to stenosis.Some surfaces displayed areas of trapped coagulated blood.Two leaflets had outward bending of the free edges near the posts due to pannus, causing mild insufficiency.All posts were covered by fibrous pannus, further narrowing the orifice.Two leaflets were nearly rigid because of heavy calcification, while the third also showed notable calcific involvement.Scarring and additional pannus deposits were observed on the crown, struts, post components, adherent margins, and leaflet surfaces.Two leaflets exhibited central pericardial delamination near the free edge.Thrombus deposits were present on the belly of one leaflet and near a post on another.Histological examination of the sampled leaflets showed marked pericardial thickening due to extensive intrinsic calcifications.One leaflet also displayed a distinct pericardial fold.Hematoxylin and eosin staining revealed disrupted, homogenized, and partially defibrated collagen bundles in both samples.Inflammatory cells were present in one leaflet.Fibrous pannus deposits were observed on the mesothelial surfaces of both leaflets and along the free edge of one of them.Thrombus deposits were found on the mesothelial surface of one leaflet and on the mediastinal surfaces of both.Pericardial delaminations were identified in both samples, including a large mesothelial delamination in one leaflet.No bacteria were detected with gram staining.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.It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this perceval valve.It should be noted that, based on the information retrieved regarding the clinical history, the patient involved in the reported event presented several risk factors for structural valve deterioration (i.E.Dyslipidemia, hypertension, diabetes mellitus type ii).As a further note, since no diagnostic images were shared with the manufacturer, it was not possible to assess if the perceval valve position was adequate to guarantee a normal functioning or if possible abnormal mechanical load and stress distribution on the prosthesis could have contributed to the early degeneration observed in this case.This aspect is particularly relevant because the valve was implanted in a patient with a bicuspid native aortic valve, a condition specifically highlighted as a warning in the ifu for these reasons.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 SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; via per crescentino sn; saluggia, bc 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 23849323
• Report Number: 3005687633-2025-00140
• Device Sequence Number: 9958230
• Product Code: LWR
• UDI-Device Identifier: 08022057014702
• UDI-Public: (01)08022057014702(240)ICV1209(17)260202
• Combination Product (Y/N): N
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 02/02/2026
• Device Model Number: PVS23
• Device Catalogue Number: PVS23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 76 KG