MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS; CP-027

Model Number	CP-027
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is following up to obtain clarification of the sequence of events.Appropriate investigative actions will be taken once further information is received.Device disposition not presently known.
Event or Problem Description
It was reported that a carboseal valsalva ascending aortic prosthesis was implanted on (b)(6) 2017 at the aortic position.On (b)(6) 2018, a crown prt valve was reportedly implanted at the same position.
Additional Manufacturer Narrative
Confirmation was received indicating that the device was explanted due to the patient's intolerance for anticoagulation therapy.There was no concern about the device functionality.The root cause of this event is clearly attributable to patient factors, and is not device-related.Device not available.
Event or Problem Description
A carboseal ascending aortic prosthesis was explanted.The device was replaced with a mitroflow valsalva conduit, size 30, and a mitroflow cna25 valve.The device was explanted due to the patient's intolerance to anticoagulation.The patient outcome was good, and there were no concerns about the functionality of the device.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Common Device Name: CP-027
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7425593
• Report Number: 3005687633-2018-00136
• Device Sequence Number: 11149087
• Product Code: LWQ
• UDI-Device Identifier: 08022057013569
• UDI-Public: (01)08022057013569(240)CP-027(17)180430
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• 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: 04/30/2019
• Device Model Number: CP-027
• Device Catalogue Number: CP-027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 04/12/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 32 YR