MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; TISSUE HEART VALVE

Model Number	CPHV
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a carbomedics top hat valve s5-023 was attempted to be implanted in a patient.Pre-procedure echo imaging measured aorta at approximately 20mm with a mean pg of 30.After initially using sizers and ruling out size 19 and 21mm, size 23mm top hat was selected based on sizing criteria.Device was implanted utilizing 12 stay sutures and cor knot system.Due to patient's small anatomy, the surgeon commented that there was little room to work around the valve during the implantation and the cor knot device was presenting some challenges.After device was implanted, aorta was closed, and patient was gradually brought off bypass and cross clamp was removed.Tee imaging at this time revealed a pvl at an area adjacent to the left coronary, the area the surgeon was stating that had little room when suturing.It was also determined that the cor knot probably perforated the aortic wall at that time contributing to the pvl.Options were discussed and it was decided to remove top hat and implant either a bioprosthetic aortic valve or another mechanical valve depending on the condition of the aorta post explant.Removing the top hat was challenging due to the snug fit.Reportedly, it was right up against stj area; and after succeeding with explant, it was decided that a conduit/mechanical valve would be the best course of action.A 19mm on-x conduit/mechanical aortic valve was selected and implanted.
Event or Problem Description
On (b)(6) 2025, a carbomedics top hat valve s5-023 was attempted to be implanted in a patient.Pre-procedure echo imaging measured aorta at approximately 20mm with a mean pg of 30.After initially using sizers and ruling out size 19 and 21mm, size 23mm top hat was selected based on sizing criteria.Device was implanted utilizing 12 stay sutures and cor knot system.Due to patient's small anatomy, the surgeon commented that there was little room to work around the valve during the implantation and the cor knot device was presenting some challenges.After device was implanted, aorta was closed, and patient was gradually brought off bypass and cross clamp was removed.Tee imaging at this time revealed a pvl at an area adjacent to the left coronary, the area the surgeon was stating that had little room when suturing.It was also determined that the cor knot probably perforated the aortic wall at that time contributing to the pvl.Options were discussed and it was decided to remove top hat and implant either a bioprosthetic aortic valve or another mechanical valve depending on the condition of the aorta post explant.Removing the top hat was challenging due to the snug fit.Reportedly, it was right up against stj area; and after succeeding with explant, it was decided that a conduit/mechanical valve would be the best course of action.A 19mm on-x conduit/mechanical aortic valve was selected, implanted and patient was moved to the usual post-operative care.Reportedly, patient remained stable through the prolongation of the surgery.Based on the information received, anatomical variances made the valve less suitable for patient and the possible perforation from the cor knot could certainly influence the presence of a pvl.
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.Since the device was not returned to the manufacturer, further investigation on the device could not be performed.However, from the document review performed, no manufacturing deficiencies were noted.Based on the information received from the field, anatomical variances made the valve less suitable for patient and the possible perforation from the cor knot could certainly influence the presence of a pvl.As such, cause of the event can be traced to non-device related factors.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL 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: 21522066
• Report Number: 3005687633-2025-00103
• Device Sequence Number: 9695771
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)290819
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• 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): 04/06/2025

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 Model Number: CPHV
• Device Catalogue Number: S5-023
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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 Sex: Female