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

Model Number CPHV

Device Problem Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Aortic Valve Stenosis (1717); No Information (3190)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer is in the process of contacting the physician to gather more information on this event.Not yet determined if device available.

Event Description

On 14th june the manufacturer was notified through patient tracking of a carbomedics top hat mechanical heart valve s5-021 which was explanted on (b)(6) 2017, after 4.54 years implant duration.A crown prt pericardial heart valve size 21 was then implanted.

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.As the device was not available for analysis, no further investigation can be performed.However, based on the document review conducted, no manufacturing deficits were identified.Prosthetic valve dysfunction at the aortic position is commonly caused by pannus formation, an inflammatory response relating to the patient's condition.The exact etiology of pannus formation is not known, but many factors can be involved in its formation.Pannus represents a bioreaction to prosthetic valves associated with coexisting factors such as surgical technique, thrombus organization from inadequate anticoagulation, infection and wall shear stress.Device not available for return.

Event Description

On (b)(6) the manufacturer was notified through patient tracking of a carbomedics top hat mechanical heart valve s5-021 which was explanted on (b)(6) 2017, after 4.54 years implant duration.A crown prt pericardial heart valve size 21 was then implanted.The valve was explanted due to prosthetic valve stenosis.The cause of the increased gradient was attributed to pannus.The device is not available for analysis.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada crescentino snc; saluggia,, vc 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia,, vc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6724909
• MDR Text Key: 80435570
• Report Number: 3005687633-2017-00076
• Device Sequence Number: 1
• Product Code: LWQ
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/04/2017
• Device Model Number: CPHV
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR