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

Model Number CP-023

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Cardiogenic Shock (2262)

Event Date 11/02/2022

Event Type  Injury  

Event Description

The manufacturer became aware of the following event through mantra study.On (b)(6) 2022, carboseal valsalva conduit/valve cp-023 was implanted in aortic position through median sternotomy.The concomitant procedure was aortic root replacement (bentall procedure).Based on the x-ray performed on (b)(6) 2022, cardiac size remained enlarged with valvular prosthesis in place.Chest tube was seen on the right with no pneumothorax.Patchy bilateral airspace consolidation and some pleural fluid could be seen that was a little worse than the day before.Based on the x-ray performed on (b)(6) 2022, minor worsening of bibasilar airspace consolidation, with appearance of the chest otherwise unchanged from the x-ray performed on (b)(6) 2022.Reportedly, cardiac arrest and hemorrhage started on (b)(6) 2022.The outcome was indicated as recovered/resolved after patient underwent a surgical procedure: bedside - thoracotomy and then in operating room - mediastinum exploration; and other non-surgical procedure: bedside bronchoscopy.

• 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: 15896329
• MDR Text Key: 304685676
• Report Number: 3019892983-2022-01047
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013545
• UDI-Public: (01)08022057013545(240)CP-023(17)230601
• 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: 11/03/2022,12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: CP-023
• Device Catalogue Number: CP-023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2022
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2022
• Date Manufacturer Received: 11/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 73 KG