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

Model Number CP-025

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

Device disposition presently unknown.

Event Description

On (b)(6) 2019 a patient received a carboseal valsalva cp-025 as part of an aortic valve replacement of a different valve implant.The device was explanted after 10 days on (b)(6) 2019 using the bentall procedure.As of now, it is unknown what device had been already implanted and why the carboseal was explanted.

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 retrieve additional information regarding the event.At this time no information has been received.Because the device is not available, and there is no further information, no additional investigations can be performed at this time.Due to the limited event information and the investigations presently possible the root cause of the event cannot be determined.The device history review confirmed the device satisfied all material, visual and performance standards required at the time of manufacture and release.Fields changed: b4, g4, g7, h2, h6.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 9263724
• MDR Text Key: 164808496
• Report Number: 3005687633-2019-00254
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013552
• UDI-Public: (01)08022057013552(240)CP-025(17)221001
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2022
• Device Model Number: CP-025
• Device Catalogue Number: CP-025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR