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

Model Number	CPHV
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Death
Event or Problem 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.
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.H3 other text : unknown disposition.
Event or Problem Description
The manufacturer was informed that a patient who underwent a reoperation with a top hat size 21 aortic mechanical valve 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.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.According to further information received, the patient annulus size was 27 mm and it was confirmed that the top hat mechanical valve was positioned supra-annularly.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h6, h11.Note: the medical device problem code has been updated based on the additional information received.Based on the information available to the manufacturer, the definite root cause of the reported event cannot ultimately be established.It should be noted though that, according to the further information received, the patient's annulus size was 27 mm, which is too small both for a perceval valve size l and a carbomedics top hat size 21 mechanical prosthesis on the basis of dimensional considerations.As such, both prostheses were undersized with respect to the patient's annulus dimensions.It is not known to the manufacturer if peculiar anatomical factors could have contributed to the undersizing of the selected prostheses.While the review of the manufacturing and material records of the top hat prosthesis involved in the reported event confirmed that this device satisfied all required material, visual, and performance standards at the time of manufacture and release, and no anomalies were found suggestive of a possible relationship between the event and the device quality, an important aspect to be considered is related to the patient's complicated clinical scenario, which could reasonably have contributed to the reported patient's death.

• 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, 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
• Report Number: 3005687633-2024-00104
• Device Sequence Number: 2858282
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)270426
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 08/30/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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: Death
• Patient Age: 75 YR
• Patient Sex: Male