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

Model Number	CPHV
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100); No Information (3190)
Date of Event	01/24/2020
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2019 a patient received a carbomedics top hat s5-023 as part of an avr.The manufacturer was notified that the device was explanted on (b)(6) 2020 and replaced with a second carbomedics s5-023.No further information was received.
Event or Problem Description
On (b)(6) 2019 a patient received a carbomedics top hat s5-023 as part of an avr.The manufacturer was notified that the device was explanted on (b)(6) 2020 and replaced with a second carbomedics s5-023.No further information was received.The manufacturer received the following additional information from the site.The reason for the explant was thrombosis secondary due to patient stopping coumadin.No device malfunction occurred and the explanted device was discarded after the procedure.Patient outcome was death.
Additional Manufacturer Narrative
The manufacturer received the following additional information from the site.The reason for the explant was thrombosis secondary due to patient stopping coumadin.No device malfunction occurred and the explanted device was discarded after the procedure.Patient outcome was death.Based on the additional information received from the site the valve thrombosis was a result of a change in the patients medication, stopping of coumadin.The site identified no valve malfunctions occurred.Based on this site assessment no further investigations will be performed and the root cause of the reported issue is deemed to be 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: 9926211
• Report Number: 1718850-2020-01060
• Device Sequence Number: 2496885
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)191117
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2020
• Report Date (Section F): 03/05/2020

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: 11/17/2019
• Device Model Number: CPHV
• Device Catalogue Number: S5-023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/05/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/04/2020
• Supplement Report FDA Received Date: 05/21/2020
• 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; Required Intervention
• Patient Age: 50 YR