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

Model Number S5-023

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/17/2018

Event Type  Injury  

Manufacturer Narrative

Device disposition presently unknown.

Event Description

On (b)(6) 2008 a patient received a carbomedics top hat s5-023 with sn (b)(4) at (b)(6) hospital in (b)(6).On (b)(6) 2018 the valve was replaced with a 2nd carbomedics top hat with the same size as the previous one which is s5-023 with sn (b)(4).No further information regarding the event was received.

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 manufacturer was unable to obtain additional information about this event, despite several attempts to follow up.However, based on the document review performed, no manufacturing deficiencies were identified.

• 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
• MDR Report Key: 8058339
• MDR Text Key: 126888567
• Report Number: 3005687633-2018-00209
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2013
• Device Model Number: S5-023
• Device Catalogue Number: CPHV
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR