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

Model Number CPHV

Device Problem Perivalvular Leak (1457)

Patient Problems Endocarditis (1834); Hypoxia (1918); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/27/2022

Event Type  Injury  

Event Description

The manufacturer was informed of this event through the patient tracking department.Based on the information received on the patient's implant forms, a carbomedics top hat valve (s5-023) was implanted on (b)(6) 2022.The device was explanted on (b)(6) 2022 and replaced with another top hat s5-023.No allegation of a device malfunction nor serious injury was received from the hospital regarding this event.Per the operational report provided, the device was explanted due to endocarditis.The patient had positive blood cultures with coag-negative staphylococcus.Patient was previously noted with an echodensity on the atrial septum.Recent transthoracic echocardiogram showed the gradient increase across both mitral and aortic valves.Aortic insufficiency was also noted.Since the patient had a recent severe deterioration of respiratory function, it was decided to to attempt the surgery to recognize if the patient's sepsis can be better controlled and to rule out valvular dysfunction due to infection.During the tee performed in or, both mitral and aortic valves seemed to be opening and closing normally.While there was increased gradient across the valve, no severe dysfunction was noted.A small paravalvular leak across the aortic valve and a thickening of atrial septum (as noted before) was noticed.No other vegetations were seen on the valve.Based on the medical note, the perivalvular leak was believed to be due to endocarditis.The patient seemed to be deteriorating despite the good antibiotic coverage.Thus, the medical decision was made to continue with the operation.During the operation, once the previous sternotomy incision was incised, there was some edema of the tissues with no obvious infection of the soft tissues or sternum.Patient was heparinized and other steps of the operation were performed.As reported during the aortic valve inspection, no vegetations or visible infection were seen on the aortic valve or annulus.Leaflets were opening and closing normally.A tiny gap between the annulus and sewing ring on the noncoronary side was noticed as a small nerve hook could pass through.The aortic valve was sharply incised and the tissue from the valve and annulus was sent for culture, but no infection on the annulus itself was visible during the surgery.The annulus was carefully debrided and all the pledgets were removed form the previous surgery, sizing was performed and size 23 carbomedics was chosen one more time to be implanted.A small strip of teflon was left between the valve ring and the aortic annulus and on the noncoronary side to prevent from any paravalvular leak in this area.A mitral valve replacement and a root enlargement were performed during the same procedure.The patient was taken to icu in stable condition.

Manufacturer Narrative

Unknown device disposition.

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 was not returned (unknown disposition), no further investigation can be performed at this time.Based on the information available, this carbomedics top hat valve (s5-023) was explanted after one month due to endocarditis.As reported, during the re-do procedure, the aortic valves seemed to be opening and closing normally.And no severe dysfunction was noted.Furthermore, the document review performed (that includes a review of the sterilization of the device) did not highlight any manufacturing deficiencies.Thus, based on the information available and investigation performed, there is no element suggesting a direct device relationship between the event and the device.Patient-related factors, or a nosocomial infection, could be the most probable root cause for the reported event.

• 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
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 14366634
• MDR Text Key: 294755260
• Report Number: 3005687633-2022-00122
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)261005
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• 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: S5-023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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: 39 YR
• Patient Sex: Male