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

Model Number S5-023

Device Problem Difficult to Open or Close (2921)

Patient Problems Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/22/2023

Event Type  Injury  

Event Description

Manufacturer was informed that a carbomedics top hat aortic heart valve (unknown model) was implanted in 2016 (no exact date).Post-operatively, respiratory failure occurred, and patient had several more strokes since 2016.Reportedly, on 22 nov 2023, the valve was explanted due to clotted pannus attributed to non-compliant with warfarin.Reportedly, patient has been stable.Based on the additional information received, the valve was unable to open or close fully due to chronic pannus and acute thrombus.Small pvl leak was also noted.Furthermore, patient has been admitted for sob and echo showed torrential aortic valve regurgitation, and pulmonary edema, with likelihood of some stenotic arterial disease in the abdomen.As reported, patient had peripheral vascular disease, and stroke in 2006, since raised chol and mild coronary artery disease.

Manufacturer Narrative

The manufacturer has received the device object of the complaint for analysis.The gross examination performed on the returned device revealed that the prosthesis is not a carbomedics top hat valve, as reported, but a cardiamed mechanical valve.Corcym will follow up with the site to assess if the device received was involved in a different event and has been returned by mistake instead of the carbomedics top hat valve or rather the device involved in the event was erroneously reported to be a carbomedics top hat valve.The manufacturer will submit a follow up report upon receival of additional information or completion of the investigation.

Manufacturer Narrative

Corcym received confirmation from the implanting site that the device involved in the event was erroneously reported to be a carbomedics top hat valve and no events occurred involving a top hat mechanical prosthesis.Since, following the gross examination performed on the returned vave, the device was identified to be a cardiamed mechanical prosthesis, corcym informed the manufacturer of the event and shared all the relevant information collected.Based on the images provided, cardiamed confirmed that the device is a product under their responsibility.The device has been made available to cardiamed to be retrieved for analysis.As such, corcym will close the case since involving a device from a different manufacturer.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Type of Device: 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, vercelli 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18457238
• MDR Text Key: 332262312
• Report Number: 3005687633-2024-00097
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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
• Device Operator: Health Professional
• Device Model Number: S5-023
• Device Catalogue Number: S5-023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR