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

Model Number CPHV

Device Problem Difficult to Open or Close (2921)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/03/2023

Event Type  Injury  

Manufacturer Narrative

The manufacturer is awaiting for the device to be returned for analysis and is following up with the site to retrieve further information regarding this event and the device involved.A follow up report will be provided upon receipt of any further information.

Event Description

The manufacturer was informed that on (b)(6) 2023, an attempt was made to implant a carbomedics top hat aortic mechanical heart valve, s5-025.At the intra-operative echo check it was observed that leaflets were not closing properly, leading to central regurgitation.The valve was replaced with a new one of the same model and size, s5-025.Based on further information received, cross clamp and bypass time increased significantly because of this event.Approximately 3 hours of clamp time were added as the surgeon decided to replace the valve after trying to repair the possible leaks and after multiple consultations.The patient's cardiac function significantly deteriorated during the procedure owing to persisting regurgitation which led to multiple vt episodes for which shock had to be delivered.

Manufacturer Narrative

Although it was anticipated that the device would be returned for investigation, the prosthesis was not received by the manufacturer after multiple attempts to follow up with the device return.As such, no investigation was possible on the device involved in this event.Due to the paucity of information retrieved from the site and since the device was not returned for investigation, the root cause of this event cannot be ultimately established.Nevertheless, the analysis of production records confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.As a further consideration, it cannot be ruled out that an unintentional impingement of one of the valve leaflets with the surgical sutures led to the reported event.Should the device be received in the future, the manufacturer will take further actions as applicable and submit a new follow up report.H3 other text: unknown device disposition.

Manufacturer Narrative

A complete manufacturing and material records review for the carbomedics top hat mechanical valve, model #s5-025 s/n #(b)(6), has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.A follow up report will be provided upon receipt of the device or of any further information.

• 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 13040 ; IT 13040
• 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: 16865281
• MDR Text Key: 314524779
• Report Number: 3005687633-2023-00111
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012920
• UDI-Public: (01)08022057012920(240)S5-025(17)270401
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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: S5-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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): Required Intervention
• Patient Sex: Female