MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS; HEART VALVE, MECHANICAL

Model Number CP-023

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/10/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 a patient received a carboseal valsalva cp-023 as part of an aortic valve replacement.The manufacturer was notified that the device was explanted and replaced with a second carboseal valsalva cp-023 on (b)(6) 2019.No further 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.The manufacturer has made several attempts to follow-up for further information but has not received any additional information at this time.The review of the device history records showed the device met all required standards at manufacture and release, however, because the device was not returned and based on the limited information available at this time the root cause of the reported event cannot be determined at this time.The conclusion is thus deemed to be cause not established.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 9547197
• MDR Text Key: 176575961
• Report Number: 1718850-2019-01230
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013545
• UDI-Public: (01)08022057013545(240)CP-023(17)210501
• 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: 12/04/2019,04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: CP-023
• Device Catalogue Number: CP-023
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2019
• Device Age: 2 YR
• Date Report to Manufacturer: 12/04/2019
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR