MAUDE Adverse Event Report: CORCYM 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	Insufficient Information (4580)
Date of Event	11/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received the following information through patient tracking department.A carboseal valsalva ascending aortic prosthesis cp-025 which was implanted on (b)(6) 2019, was explanted on (b)(6) 2022.No information has been received from the site about any allegation of device malfunction nor of serious patient injury.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 16376144
• Report Number: 3019892983-2023-01001
• Device Sequence Number: 5708316
• Product Code: LWQ
• UDI-Device Identifier: 08022057013552
• UDI-Public: (01)08022057013552(240)CP-025(17)191031
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2023
• Report Date (Section F): 01/17/2023

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: 10/31/2019
• Device Model Number: CP-025
• Device Catalogue Number: CP-025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2023
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2023
• 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: 54 YR
• Patient Sex: Male