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 Codes	Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, a carbomedics top hat mechanical heart valve s5-023 was implanted.On (b)(6) 2022, the fluoroscopy was performed due to the valve thrombus.A slight valve insufficiency was observed in one of leaflets, but the patient's symptoms were mild and treated with anticoagulant therapy.
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.Since the device remains implanted (no notification of explant received to date), no further investigation is possible at this time.The manufacturer attempted to follow up to retrieve more information, but the manufacturer was informed that no additional information will be provided on the event.Based on the information available, it is not possible to draw a definitive conclusion to the reported event.However, from the document review performed, no manufacturing deficiencies were identified.As reported, the patient's symptoms were mild and no device explant was reported as a result of the event.As such, there is no evidence to suspect a serious adverse event for the patient as a result of the event reported.Given that the patient was treated with anticoagulation therapy, it is possible that the event was caused by an incorrect management of the postoperative anticoagulation therapy.It should be noted that valve thrombosis is listed as a possible adverse event in the carbomedics prosthetic heart valve ifu.The event is, therefore, a known inherent risk of the device.Should any additional information be received in the future, a follow up report will be provided.Device remains implanted.

• 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 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 13793676
• Report Number: 3005687633-2022-00111
• Device Sequence Number: 1765434
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)240311
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 03/16/2022

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: 03/11/2024
• 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: 02/16/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• 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: Other
• Patient Age: 54 YR
• Patient Sex: Male