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

Model Number CPHV

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/11/2019

Event Type  Injury  

Event Description

On (b)(6) 2005 a patient received a carbomedics reduced r5-019 mechanical heart valve as part of an avr.The manufacturer was notified that the device was explanted and replaced with a pvs21 on (b)(6) 2019.No further information was received.

Manufacturer Narrative

The manufacturer made several attempts to follow-up for further information and no information was received.Based on the information presently available and because the device is not available for return no investigations can be performed at this time and the root cause ultimately cannot be established.

• Brand Name: CARBOMEDICS REDUCED PROSTHETIC 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: 9176859
• MDR Text Key: 161962059
• Report Number: 1718850-2019-01104
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/11/2019,12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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: R5-019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2019
• Date Manufacturer Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR