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  

Manufacturer Narrative

Device remains implanted.

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.

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.

Manufacturer Narrative

Since there is no allegation of device being explanted and the valve was not returned to the manufacturer for further investigation, the definitive root cause of the reported event cannot be established.However, from the document review performed, no manufacturing nor quality deficiencies were identified in the involved device.Should further information be received in the future, a follow up report will be provided.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 15896615
• MDR Text Key: 304635466
• Report Number: 3005687633-2022-00142
• 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
• PMA/PMN Number: P900060/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2023

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
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 73 KG