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

Model Number	R5-023
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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.

• Brand Name: CARBOMEDICS REDUCED PROSTHETIC HEART VALVE, AORTIC
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 9597240
• Report Number: 1718850-2020-00003
• Device Sequence Number: 2473996
• Product Code: LWQ
• UDI-Device Identifier: 08022057012784
• UDI-Public: (01)08022057012784(240)R5-023(17)AA04
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2020
• Report Date (Section F): 12/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: R5-023
• Device Catalogue Number: CPHV
• Was the Report Sent to FDA?: No
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/17/2019; 12/17/2019
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/06/2020; 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 87