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

Model Number	CP-025
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of this event through patient tracking database.Based on the information on the patient implant form, the carboseal valsalva size 25 that was implanted in the patient on (b)(6) 2017 has been explanted on (b)(6) 2021.No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.
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.Since the device was not returned to the manufacturer and there is no information available regarding the device disposition, no further investigation is possible.The manufacturer is following up with the field to retrieve additional information, but no further information has been received up to this date.Based on the limited information available, it is not possible to establish a definitive root cause for reported event.However, from the document review performed, no manufacturing deficiencies were identified.Should further information be received in the future, a follow up report will be provided.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Common Device Name: HEART VALVE, MECHANICAL
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 14016121
• Report Number: 3005687633-2022-00113
• Device Sequence Number: 20405246
• Product Code: LWQ
• UDI-Device Identifier: 08022057013552
• UDI-Public: (01)08022057013552(240)CP-025(17)180331
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P900060/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2022

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: 03/31/2018
• Device Model Number: CP-025
• Device Catalogue Number: CP-025
• 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: 03/11/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Unknown