MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC; MECHANICAL HEART VALVE PROSTHESIS

Model Number	A5-023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2018 a patient received a carbomedics standard prosthetic heart valve, a5-023.The manufacturer was notified that the device was explanted the same day.No further information was received.
Additional Manufacturer Narrative
The manufacturer received additional information on feb.13, 2019 from the operating physician.During the procedure the patient was identified as having paravalvular leak on toe after coming off bypass.There was no problem with the valve itself.There was a very small paravalvular leak but based on the patients young age the valve was explanted and a st.Jude medical 23atj-503, sn (b)(4), was implanted.There were no problems with the patient outcome and the site reported no valve malfunctions.Based on the information received from the site there is no device malfunction and no patient impact, therefore no further investigation will be conducted.The root cause is deemed not valve related and due to surgical/procedural errors and patient related factors.
Event or Problem Description
On (b)(6) 2018 a patient received a carbomedics standard prosthetic heart valve, a5-023.The manufacturer was notified that the device was explanted the same day.The manufacturer received additional information on feb.13, 2019 from the operating physician.During the procedure the patient was identified as having paravalvular leak on toe after coming off bypass.There was no problem with the valve itself.There was a very small paravalvular leak but based on the patients young age the valve was explanted and a st.Jude medical 23atj-503, sn (b)(4), was implanted.There were no problems with the patient outcome and the site reported no valve malfunctions.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8177164
• Report Number: 3005687633-2018-00232
• Device Sequence Number: 1747421
• Product Code: LWQ
• UDI-Device Identifier: 08022057012623
• UDI-Public: (01)08022057012623(240)A5-023(17)221002
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 02/14/2019

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: 10/02/2022
• Device Model Number: A5-023
• Device Catalogue Number: CPHV
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 02/14/2019
• 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: 48 YR