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

Model Number	CP-025
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
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.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.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 9263668
• Report Number: 1718850-2019-01154
• Device Sequence Number: 2550454
• Product Code: LWQ
• UDI-Device Identifier: 08022057013552
• UDI-Public: (01)08022057013552(240)CP-025(17)221001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020
• Report Date (Section F): 10/03/2019

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: 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
• Distributor Facility Aware Date: 10/03/2019
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 03/18/2020
• 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: 65 YR