MAUDE Adverse Event Report: CORCYM S.R.L. CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS; HEART-VALVE, MECHANICAL

Model Number	CP-027
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer was informed of the following event through device tracking department.Reportedly, on (b)(6) 2012, a carboseal valsalva valve cp-029 was implanted in a patient.The device was explanted and replaced with a perceval valve pvs27 on (b)(6)2017.No allegation of any device dysfunction or serious injury on the patient has yet been reported from the site.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 18416333
• Report Number: 3019892983-2023-01025
• Device Sequence Number: 6808118
• Product Code: LWQ
• UDI-Device Identifier: 08022057013569
• UDI-Public: (01)08022057013569(240)CP-027(17)140501
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/28/2023
• Report Date (Section F): 11/29/2023

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: 05/01/2014
• Device Model Number: CP-027
• Device Catalogue Number: CP-027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/29/2023
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2023
• 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: 47 YR
• Patient Sex: Male