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	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, a carbomedics top hat valve model s5-019 was intended for an aortic valve replacement (native valve) procedure.As confirmed, the device was tested with the dedicated tester and no fault was identified at that time.During unclamping, it was identified that the valve was stuck when opening, specifically, one leaflet did not open and did not allow flow.As such, the surgeon removed the device and tried to reposition it in the patient, first testing the valve with the dedicated testers.Then, the valve was removed, and a new carbomedics standard aortic valve was put in, which worked at the time of placement.As reported, the functionality of the top hat valve model s5-019 valve was approved, the failure was detected when unpinning and at this time it was realized that the valve leaflets did not open.There was no bad position, it was measured, tested and broken with the device's gauges and rotators correctly.
Event or Problem Description
On (b)(6) 2021, a carbomedics top hat valve model s5-019 was intended for an aortic valve replacement (native valve) procedure.As confirmed, the device was tested with the dedicated tester and no fault was identified at that time.During unclamping, it was identified that the valve was stuck when opening, specifically, one leaflet did not open and did not allow flow.As such, the surgeon removed the device and tried to reposition it in the patient, first testing the valve with the dedicated testers.Then, the valve was removed, and a new carbomedics standard aortic valve #18 was put in, which worked at the time of placement.As reported, the functionality of the top hat valve model s5-019 valve was approved, the failure was detected during the weaning from bypass and at this time it was realized that the valve leaflets did not open.The valve was already sutured, and at the time of weaning from bypass there was no movement of the leaflets, so the patient was unable to exit the extracorporeal pump.There was no bad position, it was measured, tested and broken with the device's gauges and rotators correctly.The valve was reportedly not broke or broken in the process.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Further investigation is ongoin.
Additional Manufacturer Narrative
Based on the available information, and since the device was not received for investigation, it is not possible to draw a definitive conclusion on the reported event.However, from the document review performed, no manufacturing deficiencies were identified.Despite the device was made available for return, it has not yet been received.As such, no further investigation is possible and the root cause cannot be established at this time.Should the device be received in the future, or should further information be provided, the manufacturer will update this reporting activity as appropriate.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 12021407
• Report Number: 3005687633-2021-00141
• Device Sequence Number: 1376392
• Product Code: LWQ
• UDI-Device Identifier: 08022057012890
• UDI-Public: (01)08022057012890(240)S5-019(17)250320
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 01/14/2022

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 Expiration Date: 03/20/2025
• Device Model Number: CPHV
• Device Catalogue Number: S5-019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 01/14/2022
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/27/2021; 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2020
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 55 KG