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

Model Number	CP-029
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2018 a carboseal valsalva cp-029 sn # (b)(4) aortic prosthesis was implanted.The same day (b)(6) 2018 the valve was explanted and a carboseal cp-027 sn # (b)(4) was implanted instead.No further information was received.
Additional Manufacturer Narrative
Based on the information provided, there is no indication of an adverse event or indication that carboseal size 29 was used.It is reasonable to conclude based on the sizes of the devices that the event is attributable to mis-sizing.There is no indication of device dysfunction and no further investigation is required.
Event or Problem Description
The additional information indicated that the procedure was an attempted repair, but unsuccessful.A carboseal size 27 was implanted.The operative report has no indication that the carboseal size 29 was used.The patient outcome was good and no indication of an adverse event.

• 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 ; IT 13040
• MDR Report Key: 7576096
• Report Number: 3005687633-2018-00162
• Device Sequence Number: 1776009
• Product Code: LWQ
• UDI-Device Identifier: 08022057013576
• UDI-Public: (01)08022057013576(240)CP-029(17)AA01
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 10/10/2018

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: 09/01/2021
• Device Model Number: CP-029
• Device Catalogue Number: CP-029
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: Required Intervention
• Patient Age: 53 YR