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

Model Number CP-027

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2017

Event Type  Injury  

Event 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
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 18416333
• MDR Text Key: 331580064
• Report Number: 3019892983-2023-01025
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013569
• UDI-Public: (01)08022057013569(240)CP-027(17)140501
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2023,12/28/2023

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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male