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	Degraded (1153)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified from the mantra study database of the early explant of a perceval plus valve.The following provides a summary of all information currently available to the manufacturer.A perceval plus pvf-s valve was successfully implanted in a female patient on (b)(6) 2022.At the 3-year follow-up visit, echocardiography revealed a mean aortic pressure gradient of 68 mmhg, moderate central regurgitation, and a left ventricular ejection fraction of 50%.Functionally, the patient was classified as nyha class iii prior to the initial perceval valve implantation, improved to nyha class ii following the procedure, and subsequently deteriorated to nyha class iii at the 3-year postoperative follow-up.The patient presented again on (b)(6) 2026 with severe aortic stenosis.Following diagnostic evaluation and hospitalization, the prosthetic valve was explanted on (b)(6) 2026 and replaced via median sternotomy with a 19-mm bicarbon fitline valve (sn (b)(6)).The patient's medical history includes systemic hypertension, type ii non-insulin-dependent diabetes mellitus, dyslipidemia, current tobacco use, and obesity.
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 if the device is retrieved and when further information is received from the site.
Event or Problem Description
The manufacturer was notified from the mantra study database of the early explant of a perceval plus valve.The following provides a summary of all information currently available to the manufacturer.A perceval plus pvf-s valve was successfully implanted in a female patient on (b)(6) 2022.At the 3-year follow-up visit, echocardiography revealed a mean aortic pressure gradient of 68 mmhg, moderate central regurgitation, and a left ventricular ejection fraction of 50%.Functionally, the patient was classified as nyha class iii prior to the initial perceval valve implantation, improved to nyha class ii following the procedure, and subsequently deteriorated to nyha class iii at the 3-year postoperative follow-up.The patient presented again on (b)(6) 2026 with severe aortic stenosis.Following diagnostic evaluation and hospitalization, the prosthetic valve was explanted on (b)(6) 2026 and replaced via median sternotomy with a 19-mm bicarbon fitline valve (sn (b)(6)).The patient¿s medical history includes systemic hypertension, type ii non-insulin-dependent diabetes mellitus, dyslipidemia, current tobacco use, and obesity.Further information from the site indicated that explanted device will not be returned to the manufacturer.The device was sent sent to the microbiology lab for analysis and therefore it has been dismantled.The analyzed sample produced the following result: no growth detected.Also, the patient outcome is reported as recovered/resolved.
Additional Manufacturer Narrative
Updated sections: b4, b5, d9, g3, g6, h2, 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.Since the valve has not been returned to the manufacturer, an evaluation of the device cannot be performed.However, the review of the manufacturing records did not reveal any device deficiencies.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 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).Ultimately, it should be considered that structural valve deterioration is listed as a possible adverse event in the perceval ifu.

• 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: 24939216
• Report Number: 3004478276-2026-00134
• Device Sequence Number: 17438237
• Product Code: LWR
• UDI-Device Identifier: 08022057015365
• UDI-Public: (01)08022057015365(240)PVF-S(17)260107
• 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: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: 01/07/2026
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: No
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2022
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 187 LB