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

Model Number CPHV

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

Device available but not yet received.

Event Description

A carbomedics standard prosthetic heart valve was explanted after one year due to thrombosis resulting in leaflet dysfunction.

Event Description

On (b)(6) 2018, manufacturer received information that at the time of implant the patient was diagnosed with severe mitral regurgitation and stenosis with an la-clot.In the procedure, mitral valve replacement and la clot removal were performed.The valve was implanted on (b)(6) 2016.

Manufacturer Narrative

The manufacturer was unable to acquire any further information pertaining to the case.The device was not received and no further investigations could be performed.If further information or the device is received the investigation will be reopened for analysis.Fields changed; device not received.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC 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
• MDR Report Key: 7131708
• MDR Text Key: 95320492
• Report Number: 3005687633-2017-00137
• 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: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CPHV
• Device Catalogue Number: M7-029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 56