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

Model Number	S5-021
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endocarditis (1834); No Information (3190)
Date of Event	07/26/2019
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 tophat s5-021 mechanical heart valve as part of an avr.The manufacturer was notified that the device was explanted on (b)(6) 2019 and replaced with a s5-023.No further information was received.
Event or Problem Description
On (b)(6) 2018 a patient received a carbomedics tophat s5-021 mechanical heart valve as part of an avr.The manufacturer was notified that the device was explanted on (b)(6) 2019 and replaced with a s5-023.Additional information received on (b)(6) 2019 identified that the valve was explanted as a result of endocarditis.There were no device malfunctions identified and the patient was discharged without complications.Based on this assessment there is no reasonable information suggesting a relationship between the device and the endocarditis.
Additional Manufacturer Narrative
Additional information received on (b)(6) 2019 identified that the valve was explanted as a result of endocarditis.There were no device malfunctions identified and the patient was discharged without complications.Based on this assessment there is no reasonable information suggesting a relationship between the device and the endocarditis.Based on the additional information received there is no reasonable information suggesting a relationship between the device and the endocarditis as the device had no malfunctions, and there were no information included in the follow-up identifying a device relationship.At this time no investigations will be performed and the case will be closed as not device related.The event conclusion is thus cause cannot be traced to device : adverse event related to patient condition.

• Brand Name: CARBOMEDICS TOP HAT 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: 9177358
• Report Number: 3005687633-2019-00231
• Device Sequence Number: 2830617
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)220206
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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: 02/06/2022
• Device Model Number: S5-021
• Device Catalogue Number: S5-021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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: 37 YR