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

Model Number	CPHV
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a carbomedics top hat valve, s5-021 was successfully implanted.Once all sutures were in place, they started rotating the leaflets with a rubber shodded hemostat and a debakey.It was at this time that the leaflet broke.They had to remove the pieces, flush and suction the area as well as remove the top hat valve and place a second one.This added at least an hour to the case.The second top hat was placed successfully.As reported patient is doing well and was coming out of the icu and to the floor with stable hemodynamic and extubated.
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.Manufacturer is pending the receipt of the device for further investigation.A follow up report will be provided upon receipt of the device and/or completion of the investigation.
Additional Manufacturer Narrative
Updated sections b4, d9, g3, g6, h2, h6.Manufacturer has received the device for further investigation.Furthermore, manufacturer is retrieving and reviewing the production documents.A follow up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
Updated sections b4, g3, g6, h2, h3, h6, h11 the device was returned to the manufacturer.Following decontamination in formalin and subsequent treatment with hypochlorite solution, the prosthesis was visually inspected.No pre-existing defects were identified, but chipped areas were detected in both pivots corresponding to the position of the missing leaflet.The undamaged leaflet was identified as the left leaflet, while the broken leaflet corresponded to the right position.X-ray performed to exclude voids, flaws, and irregularities in the internal structure of the leaflet.Proof function tests performed on the separate leaflets and on the assembly.These tests are followed by dye liquid penetrant inspection with the aim to exclude component failures.From the document review performed, no manufacturing deficiencies were noted.Among the possible mishandling scenarios documented in the literature that could lead to valve damage, some produce fracture effects fully comparable to the observed failure mode.Specifically, an over-rotation can generate an excessive load resulting in the sudden breakage and escape of the leaflet from the orifice, while simultaneously causing damage to the pivot contact areas.Considering the description reported in the case history: ¿started rotating the leaflets with a rubber-shodded hemostat and a debakey¿, it is important to emphasize that, based on the illustrated scenario, the root cause of the fracture is primarily associated with the use of rigid instruments.The leverage effect of a clamp (even if protected), combined with the inherent lever provided by the leaflet itself, can induce a fracture under a relatively low load, which may be barely perceptible to the operator.It is important to note that rubber protection on the instrument tips cannot be considered an effective preventive measure against this type of stress.While it may reduce the risk of surface scratches during direct contact, it does not mitigate the mechanical leverage effect generated by rigid instruments during rotation.Even with rubber-shodded tips, the combined leverage of the clamp and the leaflet itself can generate forces sufficient to cause fracture, without being easily perceived by the operator.It should also be noted that, as reported in the device ifus, the valve shall be rotated in situ to the desired position exclusively by using the holder still assembled with the handle.The use of any other instrument or device to rotate the valve by grasping one or both leaflets may cause severe, non-visible damage which may result in valve malfunction.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• 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: 22847320
• Report Number: 3005687633-2025-00126
• Device Sequence Number: 20933477
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)300307
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,Followup
• Report Date (Section B): 01/21/2026

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: S5-021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 11/20/2025; 12/22/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 12/20/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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: 58 YR
• Patient Sex: Female