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

Model Number	PVS25
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note: the manufacturer received the device's model and serial number as additional information.It was noted though that the prosthesis's size reported in the paper does not match the data provided.The manufacturer will submit a follow up report upon receipt of a clarification on this matter.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.Based on the information available the cause of the event is related to the structural valve deterioration.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).As a further note, since no diagnostic images were available for evaluation, 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.Ultimately, it should be considered 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.
Event or Problem Description
Information obtained from a published paper entitled: " emergency transcatheter aortic valve in sutureless valve replacement for managing cardiogenic shock", by alessandro comis, et al.The abstract indicted the following: ¿sutureless aortic bioprosthesis (sbvs) may pose specific challenges to valve-in-valve (viv) implantation, particularly, in the setting of cardiogenic shock which remains challenging and understudied.Paper reports a patient with a sbvs disfunction, presenting with acute decompensated hf.Despite intra-aortic balloon pump (iabp), clinical deterioration prompted an emergency transcatheter viv.Computer tomography imaging confirmed procedural feasibility.A self-expanding evolut pro+ valve was deployment followed by post-dilatation for under expansion.The procedure restored valve function, and the patient was weaned off iabp.At 30-day follow-up, patient was in nyha class i with complete recovery of left ventricular systolic function (ef 53%).Careful ct planning and device selection are critical.Despite the lack of data in this setting, viv may represent a safe and effective option for high-risk patients in cardiogenic shock (cs)¿.Based on the further information received, a patient with acute episodes of heart failure (hf) presented to the emergency department.His medical history included surgical aortic valve replacement with a perceval valve size m in 2019 for severe aortic stenosis.Comorbidities included hypertension, dyslipidemia, type ii diabetes, and a history of smoking.Transthoracic echocardiography (tte) revealed a severely reduced ejection fraction (ef) and svd of the bioprosthesis, leading to severe stenosis.The patient was referred for redo surgical aortic valve replacement after stabilization of acute hf, given patient's age and a surgical risk profile (sts mortality score 5.67%).During hospitalization at the center, despite optimal medical therapy including intravenous diuretics, the patient experienced worsening heart failure (hf) with cardiogenic shock (cs) requiring vasopressor support and intra-aortic balloon pump (iabp) assistance.A thoracic computer tomography (ct) revealed a severe worsening of the pulmonary congestion with diffuse interstitial edema.Due to the clinical deterioration and a significant increase in surgical risk (sts mortality score 26.9%), also related to a drop in ef (20%), an emergency percutaneous viv was indicated.Final angiography showed good expansion of the thv, correct cusp alignment, no paravalvular leaks, and preserved coronary flow.Following the procedure, iabp support was no longer needed, and vasopressors were gradually weaned off.The patient was discharged in nyha class ii 5 days after viv, predischarge tte showed mildly improved ef (27%) and excellent prosthesis function.Based on the further information received, the perceval prosthesis was implanted on (b)(6) 2020.
Additional Manufacturer Narrative
Updated sections: g3, g6, h2, h11.The manufacturer received confirmation from the cardiologist who authored the publication that the valve size reported in the paper was incorrect; the actual valve that the patient had implanted was the perceval s icv1210 (b)(6) size l referenced in the initial report.

• 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: 22961137
• Report Number: 3004478276-2025-00172
• Device Sequence Number: 9515050
• Product Code: LWR
• UDI-Device Identifier: 08022057014719
• UDI-Public: (01)08022057014719(240)ICV1210(17)240409
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: 04/09/2024
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2020
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 70 KG