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

Model Number	CP-025
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/27/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
This event is being reported in a conservative manner, due to the proximity of the patient's death to the date of implantation.The manufacturer is presently following up to determine the possible relationship of the event to the device.Device disposition not presently known.
Event or Problem Description
A carboseal valsalva ascending aortic prosthesis was implanted on (b)(6) 2017.The patient passed away on (b)(6) 2018.
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 was unable to obtain additional information about this event, and did not receive the device for analysis.The root cause of the event therefore cannot be determined.Based on the information available to date, there is no known link between the event and the device.The event was reported in a conservative manner.

• 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 13040 ; CA 13040
• MDR Report Key: 7382391
• Report Number: 3005687633-2018-00130
• Device Sequence Number: 1393548
• Product Code: LWQ
• UDI-Device Identifier: 08022057013552
• UDI-Public: (01)08022057013552(240)CP-025(17)191031
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: CP-025
• Device Catalogue Number: CP-025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 04/27/2018
• 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: Death
• Patient Age: 58 YR