MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; MECHANICAL HEART VALVE PROSTHESIS

Model Number CPHV

Device Problem Perivalvular Leak (1457)

Patient Problem Mitral Regurgitation (1964)

Event Date 09/01/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018, the patient received a carbomedics standard mitral valve.The patient was not recovering well following the procedure and the echo suggested a paravalvular leak.Consequently, the surgeon re-opened on the (b)(6).Upon inspection, the surgeon found that the implantation was good but one of the valve leaflets appeared very stiff and not opening.Therefore, the carbomedics valve was explanted and the valve replaced with another company's valve.

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.The returned prosthesis valve was received with te sewing cuff blood stained and slightly covered by organic depositions.Investigation is ongoing.

Event Description

The native mitral leaflets were retained during the procedure.

Manufacturer Narrative

Visual inspection of the returned device confirmed the absence of manufacturing defects.Hydrodynamic testing was performed on the returned device, and neither leaflet blockage or sticky behavior was detected.Based on the investigations performed, no mechanical malfunction could be identified and the event cannot be traced to the involved device.The root cause remains unknown; however, the device can reasonably be excluded as a contributing factor to the event.

Event Description

On (b)(6) 2018, the patient received a carbomedics standard mitral valve.After coming off pump paravalvular leak was identified.The physician reopened the aorta, tested the leaflets with a tester, and found no problem.They then came off bypass and completed the procedure.The patient was not recovering well following the procedure and echocardiography suggested central leak.It was reported that one of the valve leaflets appeared to be stiff and not opening.Consequently, the surgeon re-operated on the 1st of september.The leaflets were tested again upon re-operation, but moved freely.The carbomedics valve was explanted and the valve was replaced with an onyx valve of the same size.No concomitant procedures were performed and the echocardiogram was not available.The native mitral leaflets were retained during the initial procedure.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 7920665
• MDR Text Key: 122130935
• Report Number: 3005687633-2018-00193
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012746
• UDI-Public: (01)08022057012746(240)M7-031(17)181108
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2018
• Device Model Number: CPHV
• Device Catalogue Number: M7-031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention