MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE, AORTIC; MECHANICAL HEART VALVE PROSTHESIS

Model Number CPHV

Device Problem Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

Not available for return.

Event Description

A carbomedics top hat, size 21, was implanted on (b)(6) 2005.The valve was explanted thirteen years later, on (b)(6) 2018.It was reported that the valve was heavily calcified with significant calcification of the posterior leaflet and annulus; however, it was unclear whether the reported calcification was associated with the native valve failure, or the top hat 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.Based on the information provided, the device was left in place following resection of extensive pannus overgrowth.Given that the device was not explanted, and was functioning well post-operatively, it can be inferred that the dysfunction was not suspected to be inherent to the device, but was rather associated with the patient's specific clinical condition.As the device was not explanted, no investigation can be performed and the root cause cannot be established; however, from the document review performed, no manufacturing deficiencies were identified.Updated fields: date of report , concomitant medical products, device evaluated by mfr.Device still implanted.

Event Description

A carbomedics top hat, size 21, was implanted on (b)(6), 2005.Re-operation was performed thirteen years later, on (b)(6), 2018 due to severe prosthetic aortic stenosis and severe mitral valve stenosis.The s5-021 aortic valve had significant pannus circumferentially (approximately 3 millimeters).The pannus was removed without disrupting the valve, and the valve was left in place.Concomitant mvr was performed.Post-operative echo showed normally functioning aortic and mitral prostheses.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE, AORTIC
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8072444
• MDR Text Key: 127201512
• Report Number: 3005687633-2018-00212
• Device Sequence Number: 1
• Product Code: LWQ
• 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
• Report Date: 02/01/2019

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 Expiration Date: 01/01/2010
• Device Model Number: CPHV
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 11/29/2018; 01/10/2019
• Supplement Dates FDA Received: 12/20/2018; 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR