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

Model Number	CP-023
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Cardiogenic Shock (2262)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem 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.
Additional 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.
Additional 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.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Common Device Name: 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
• Report Number: 3005687633-2022-00142
• Device Sequence Number: 5209831
• Product Code: LWQ
• UDI-Device Identifier: 08022057013545
• UDI-Public: (01)08022057013545(240)CP-023(17)230601
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P900060/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2023

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 12/05/2022; 02/02/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/04/2023; 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 73 KG