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

Model Number A5-023

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

Device disposition presently unknown.

Event Description

On (b)(6) 2018 a patient received a carbomedics standard prosthetic heart valve, a5-023.The manufacturer was notified that the device was explanted the same day.No further information was received.

Manufacturer Narrative

The manufacturer received additional information on feb.13, 2019 from the operating physician.During the procedure the patient was identified as having paravalvular leak on toe after coming off bypass.There was no problem with the valve itself.There was a very small paravalvular leak but based on the patients young age the valve was explanted and a st.Jude medical 23atj-503, sn (b)(4), was implanted.There were no problems with the patient outcome and the site reported no valve malfunctions.Based on the information received from the site there is no device malfunction and no patient impact, therefore no further investigation will be conducted.The root cause is deemed not valve related and due to surgical/procedural errors and patient related factors.

Event Description

On (b)(6) 2018 a patient received a carbomedics standard prosthetic heart valve, a5-023.The manufacturer was notified that the device was explanted the same day.The manufacturer received additional information on feb.13, 2019 from the operating physician.During the procedure the patient was identified as having paravalvular leak on toe after coming off bypass.There was no problem with the valve itself.There was a very small paravalvular leak but based on the patients young age the valve was explanted and a st.Jude medical 23atj-503, sn (b)(4), was implanted.There were no problems with the patient outcome and the site reported no valve malfunctions.

• Brand Name: CARBOMEDICS STANDARD 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: 8177164
• MDR Text Key: 130764130
• Report Number: 3005687633-2018-00232
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012623
• UDI-Public: (01)08022057012623(240)A5-023(17)221002
• 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
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2022
• Device Model Number: A5-023
• Device Catalogue Number: CPHV
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR