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

Model Number	PVF-M
Medical Device Problem Codes	Collapse (1099); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of the following event through mantra study database.Reportedly, a perceval plus valve, pvf-m, was implanted in the patient on (b)(6) 2025.Based on the information received, an inward deformation of the perceval valve was identified on (b)(6) 2025.Further details indicated that the valve demonstrated good functionality in both the post-operative and discharge echos, with no increase in gradients or signs of regurgitation.The patient's annulus was reported to measure around 22/23 mm, likely ruling out concerns of oversizing.According to additional input from the surgeon, the patient had a bicuspid valve with a fibrous raphe, with the inward deformation suspected to be located in that area.On (b)(6) 2025, a femoral valvuloplasty was performed using a 23 mm balloon inflated to 4.5 bar in an effort to expand the perceval valve.A post-procedure ct scan showed slight improvement, although the deformation remained visible.Despite this, the echo findings continued to show good valve performance, with no high gradients or regurgitation.Given the valve¿s satisfactory function and the observed improvement, the surgeon opted to leave the valve in place.The site reported the outcome as recovered/resolved as of (b)(6) 2025.The patient's medical history includes chronic lung disease and systemic hypertension.
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 remains implanted and therefore is not accessible for testing.As such, further investigation cannot be performed.Based on the manufacturer¿s experience and on the additional information received, it is reasonable to conclude that the reported inward deformation of the perceval prosthesis was likely caused by the patient¿s bicuspid native aortic valve anatomy, as also suggested by the implanting surgeon.It is important to note that, according to the device's ifu, careful consideration of perceval prosthesis' use is recommended in patients with congenital bicuspid aortic valve, as data from clinical or in vitro testing are not available to establish its safe use in such cases.In addition, considering that the device was ultimately left in place with a reportedly good funtionality and no anomalies were identified during the review of the production records, a device deficiency can be excluded as cause or contributory cause of the event.
Additional Manufacturer Narrative
Updated sections: b4, b5, g3, g6, h2, h11.Corrected sections: h6.Ct scans confirming the presence of the infolding were shared with the manufacturer.The wording of the event description (in section b5) and conclusion (in section h11), as well as the coding (section h6) have been updated accordingly.Based on the manufacturer¿s experience and on the additional information received, it is reasonable to conclude that the reported infolding of the perceval prosthesis was likely caused by the patient¿s bicuspid native aortic valve anatomy, as also suggested by the implanting surgeon.It is important to note that, according to the device's ifu, careful consideration of perceval prosthesis' use is recommended in patients with congenital bicuspid aortic valve, as data from clinical or in vitro testing are not available to establish its safe use in such cases.In addition, considering that the device was ultimately left in place with a reportedly good functionality and no anomalies were identified during the review of the production records, a device deficiency can be excluded as cause or contributory cause of the event.
Event or Problem Description
The manufacturer was informed of the following event through mantra study database.Reportedly, a perceval plus valve, pvf-m, was implanted in the patient on (b)(6) 2025.An infold of the perceval valve was identified on (b)(6) 2025, based on the information provided.The site reported that the adverse event began on (b)(6) 2025, and that the infold was first recognized on (b)(6) 2025.Further details indicated that the valve demonstrated good functionality in both the post-operative and discharge echos, with no increase in gradients or signs of regurgitation.The patient¿s annulus was reported to measure around 22/23 mm, likely ruling out concerns of oversizing.According to additional input from the surgeon, the patient had a bicuspid valve with a fibrous raphe, with the infold suspected to be located in that area.On (b)(6) 2025, a femoral valvuloplasty was performed using a 23 mm balloon inflated to 4.5 bar in an effort to expand the perceval valve.A post-procedure ct scan showed slight improvement, although the deformation remained visible.Despite this, the echo findings continued to show good valve performance, with no high gradients or regurgitation.Given the valve¿s satisfactory function and the observed improvement, the surgeon opted to leave the valve in place.The site reported the outcome as recovered/resolved as of (b)(6) 2025.The patient's medical history includes chronic lung disease and systemic hypertension.

• 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
• 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: 23552215
• Report Number: 3004478276-2025-00186
• Device Sequence Number: 9457908
• Product Code: LWR
• UDI-Device Identifier: 08022057015372
• UDI-Public: (01)08022057015372(240)PVF-M(17)290531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/17/2025

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 Model Number: PVF-M
• Device Catalogue Number: PVF-M
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2025
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 72 KG