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	Positioning Failure (1158); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/04/2025
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 device has been returned to the manufacturer.An investigation on the device is ongoing.Manufacturer is also following up with the healthcare facility to gather additional information regarding the reported event.A follow-up report will be submitted upon completion of investigation on the device and/or availability of new relevant information.
Event or Problem Description
The manufacturer was notified of an intraoperative explant related to a perceval plus suturless aortic heart valve size m that occurred on (b)(6) 2025.The patient¿s native valve had been replaced due to aortic insufficiency.During implantation, the prosthetic valve had been repositioned twice due to complications described as ¿pop-up of the device¿.Subsequently, restricted leaflet motion was observed, resulting in severe central valve insufficiency, which led to the decision to explant the device.A size 23 stented biological valve was implanted as a replacement.The event resulted in a second aortic cross-clamping and a prolonged myocardial ischemia time.
Additional Manufacturer Narrative
Updated sections: a4, b4, b5, g3, g6, h2, h3, h6, h11.Corrected sections: h1.The returned valve was received in the explant kit¿s plastic jar filled with unknown liquid.Overall, the returned prosthesis appeared to be in good storage condition.After decontamination, the valve was visually inspected without highlighting elements of non-conformity according to the specifications.A dimensional analysis was conducted to ensure the device met the specifications.The height of each leaflet was verified resulting in conformity.Both the valve inflow skirt and the sinusoidal structures were found to be compliant.To investigate the reported central leak, hydrodynamic testing was performed.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction was 2.8% and the effective orifice area was 3.19 cm2, which is below the requirement of iso 5840 (rf% < 10% and eoa > 1.25 cm2) for a prosthesis of equivalent size.No opening or coaptation anomalies were detected both in normotensive and hypotensive conditions.This is further supported by the steady flow test images taken prior to product release, which show no signs of abnormal behavior and demonstrate consistent leaflet morphology during opening and closing.Based on the analysis conducted, the reported event cannot be attributed to any intrinsic factor related to the device itself, as no anomalies were observed during the investigation.Specifically, no hypomobile leaflet and central leak were detected either during the hydrodynamic test nor in the images from the steady flow test performed prior to product release.The reported ¿pop-up¿ of the device may be due to a complex annular anatomy that potentially led to malpositioning.However, a definitive root cause could not be determined.
Event or Problem Description
The manufacturer was notified of an intraoperative explant related to a perceval plus suturless aortic heart valve size m that occurred on (b)(6) 2025.The patient¿s native valve had been replaced due to aortic insufficiency.During implantation, the prosthetic valve had been repositioned twice due to complications described as ¿pop-up of the device¿.Subsequently, restricted leaflet motion was observed, resulting in severe central valve insufficiency, which led to the decision to explant the device.A size 23 stented biological valve was implanted as a replacement.The event resulted in a second aortic cross-clamping and a prolonged myocardial ischemia time.The hospital notified the italian ministry of health of the incident on (b)(6) 2025.Based on the further information received, two days after surgery the patient developed hyposthenia of the left lower limb, and brain ct scan revealed an ischemic stroke.On the following day (b)(6), the patient was reintubated due to worsening neurological and respiratory status.Thoracic ct and microbiological tests confirmed the presence of pneumonia.Due to prolonged mechanical ventilation, a tracheostomy was performed.On (b)(6), the patient developed atrial fibrillation.Subsequently, cholecystitis was diagnosed.At the time of discharge, all issues had been resolved, and the patient was in good clinical condition.Reportedly.The surgery was isolated with ministernotomy approach with no concomitant procedures.During collapsing and releasing of the valve no problem was noted.After the valve was implanted, they immediately recognized that it was positioned above the aortic annulus.As reported, perimount magna ease 23 mm was ultimately implanted in the patient.The additional cpb time was 103 minutes, and the additional cross-clamp time was 86 minutes.The patient was hemodynamically stable during the whole procedure.The abnormal movement of the leaflet were noted in the intraoperative echo images.

• 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 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: 22399597
• Report Number: 3004478276-2025-00153
• Device Sequence Number: 15596814
• Product Code: LWR
• UDI-Device Identifier: 08022057015372
• UDI-Public: (01)08022057015372(240)PVF-M(17)281124
• 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): 09/04/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2024
• 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: 86 KG