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

Model Number R5-023

Device Problem Insufficient Information (3190)

Patient Problem Endocarditis (1834)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

Device disposition presently unknown.

Event Description

On (b)(6) 2018 a patient received a carbomedics reduced r5-023 as part of the sure-avr trial.The manufacturer was notified of a serious adverse event which occurred on (b)(6) 2019.The patient received a reintervention due to valve endocarditis.The device was explanted.No replacement valve was identified.No further event information or patient information 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.

Manufacturer Narrative

The manufacturer has made several attempts to obtain further information from the site.At this time no further details regarding the event or device availability have been received.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.Ultimately, based on the limited information available regarding the event and the device functionality between the time of implant and the time of explant, it is not possible to draw a definitive conclusion to the reported event.If the manufacturer receives additional information, the investigation will be reassessed.Fields changed: b4, g4, g7, h2, h6.

• 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: 9597277
• MDR Text Key: 175253132
• Report Number: 3005687633-2020-00099
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012784
• UDI-Public: (01)08022057012784(240)R5-023(17)AA04
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: R5-023
• Device Catalogue Number: CPHV
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 02/07/2020; 04/29/2020
• Supplement Dates FDA Received: 03/06/2020; 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 87