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

Model Number CPHV

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

The manufacturer was informed that a patient who underwent a reoperation with a carbomedics top hat aortic mechanical valve size 21 passed away.The top hat valve had been implanted to replace a sutureless aortic bioprosthesis (perceval plus size l, sn (b)(6)) which had shown a leaflet not coapting completely leading to central leak (vigilance reports submitted to fda on 14-feb-2024 and 21-mar-2024, corcym ref.(b)(4)).As per information received, the reoperation was carried out in the evening of the same day of perceval valve implant.Approximately 8 hours later.Reportedly, the patient was already very complicated.The preoperative echocardiography was showing the following values: aortic valve area (ava) 1 square centimeter with a mean gradient of 46/25 mmhg, severe mitral regurgitation (mr) for 2-3 months, grade 2 tricuspid regurgitation (tr), pulmonary artery pressure (pap) of 45 mmhg, ef %45.The patient had undergone stenting of the rca and cx arteries one year before; the stents were found patent in the preoperative coronary angiography.The manufacturer is following up with the site to retrieve further information on the event and the device involved.

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.H3 other text : unknown disposition.

• 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, vc 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18986344
• MDR Text Key: 338704435
• Report Number: 3005687633-2024-00104
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)270426
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 03/27/2024

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: CPHV
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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): Death
• Patient Age: 75 YR
• Patient Sex: Male