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	Collapse (1099)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is further following up with the involved healthcare facility to retrieve additional information on the patient's status and on the event.A follow-up report will be submitted upon availability of new details and completion of the investigation on the returned device.
Event or Problem Description
The manufacturer was notified of the early explant of a perceval plus aortic heart valve, pvf-s.The prosthesis had been implanted on (b)(6) 2025, in a patient with a steno-insufficient tricuspid native aortic valve.Reportedly no positioning difficulties or oversizing were identified during the implantation procedure.According to reports, a hemodynamically significant paraprosthetic leak developed 15 days post-implant, prompting the explantation of the valve on (b)(6) 2025.Upon removal, the site observed a deformation characterized by inward folding localized at the non-coronary sinus, suggesting incomplete expansion over approximately one centimeter of the valve¿s circumference.According to the site's assessment, at this location, the nitinol stent demonstrated an abnormal weakness.During the reoperation, manual re-expansion of the prosthesis following saline irrigation proved successful, allowing for proper adherence to the aortic annulus.Nevertheless, due to concerns regarding a potential structural defect, the valve was explanted.According to the information received, the abnormal behavior of the nitinol stent could be reproduced after the removal.The perceval valve was replaced with an edwards inspiris size 23 prosthesis.The patient developed acute kidney injury following the reoperation which, according to the surgeon¿s assessment, is linked to the patient¿s obesity.The patient is reported to be in semi-intensive care unit, monitored and in recovery.
Additional Manufacturer Narrative
Updated section: 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, and it was received on november 10, 2025.The returned valve was received in the explant kit, inside the provided plastic jar filled with an unknown liquid.The returned prosthesis appeared in general good storage conditions.After decontamination, the valve was visually inspected, and no elements of manufacturing non-conformity were identified according to the specifications in terms of geometrical aspects.A slight crease in the pericardium of the third leaflet was observed, most likely caused by the reported stent infolding.In the same region, the areas where the stent had folded appear darker beneath the pericardium, indicating that the valve may have remained in the folded configuration for an extended period.The correct dimensions of the returned device were confirmed through the use of the appropriate tool.In order to attempt to reproduce the reported event, a replication of collapsing phases was performed using the returned valve pvf-s and a demo accessory kit.No problems were encountered in positioning and collapsing the returned valve.During the valve deployment and ballooning phase in the silicon aortic root (size 21), no problems were encountered.The valve positioning and sealing at the annulus level were guaranteed, and the prosthesis remained fixed within the annulus without observing significant anomalies.Inserting some water in the aortic root from the outflow side, and considering the static conditions of the test, no paravalvular leaks were observed during the simulation and the water level remained stable under the leaflets free edge.Based on the analyses carried out, it is possible to exclude a relationship between the reported issue and the quality of the returned device.As none of the reported issues were reproducible during the investigation, it was not possible to determine a definitive root cause.
Event or Problem Description
The manufacturer was notified of the early explant of a perceval plus aortic heart valve, pvf-s.The prosthesis had been implanted on (b)(6) 2025, in a patient with a steno-insufficient tricuspid native aortic valve.Reportedly no positioning difficulties or oversizing were identified during the implantation procedure.According to reports, a hemodynamically significant paraprosthetic leak developed (b)(6) days post-implant, prompting the explantation of the valve on (b)(6) 2025.Upon removal, the site observed a deformation characterized by inward folding localized at the non-coronary sinus, suggesting incomplete expansion over approximately one centimeter of the valve¿s circumference.According to the site's assessment, at this location, the nitinol stent demonstrated an abnormal weakness.During the reoperation, manual re-expansion of the prosthesis following saline irrigation proved successful, allowing for proper adherence to the aortic annulus.Nevertheless, due to concerns regarding a potential structural defect, the valve was explanted.According to the information received, the abnormal behavior of the nitinol stent could be reproduced after the removal.The perceval valve was replaced with an edwards inspiris size 23 prosthesis.The patient developed acute kidney injury following the reoperation which, according to the surgeon¿s assessment, is linked to the patient¿s obesity.Based on additional information received, the patient is progressing well in rehabilitation and the cardiac health remains stable.The manufacturer was informed that no diagnostic images could be retrieved.

• 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 S.R.L.; via per crescentino sn; saluggia, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 23542604
• Report Number: 3005687633-2025-00134
• Device Sequence Number: 21253489
• Product Code: LWR
• UDI-Device Identifier: 08022057015365
• UDI-Public: (01)08022057015365(240)PVF-S(17)290418
• 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
• Device Explanted Year: 2025
• 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): 12/19/2025

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-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 84 KG