MAUDE Adverse Event Report: SORIN GROUP ITALIA 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 Code	No Information (3190)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the present time the manufacturer has not received any further information regarding the event or information about the device location.If additional information is received the manufacturer will perform the relevant investigations.Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2019 a patient received a carboseal valsalva cp-023 as part of an aortic valve replacement.The manufacturer was notified that the device was explanted and replaced with a second carboseal valsalva cp-023 on (b)(6) 2019.No further information was received.
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.The manufacturer has made several attempts to follow-up for further information but has not received any additional information at this time.The review of the device history records showed the device met all required standards at manufacture and release, however, because the device was not returned and based on the limited information available at this time the root cause of the reported event cannot be determined at this time.The conclusion is thus deemed to be cause not established.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Common Device Name: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 9547385
• Report Number: 3005687633-2020-00096
• Device Sequence Number: 2374986
• Product Code: LWQ
• UDI-Device Identifier: 08022057013545
• UDI-Public: (01)08022057013545(240)CP-023(17)210501
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 05/01/2021
• Device Model Number: CP-023
• Device Catalogue Number: CP-023
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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: 20 YR