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

Model Number CPHV

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Death (1802); Thrombosis (2100); No Information (3190)

Event Date 01/24/2020

Event Type  Death  

Manufacturer Narrative

Device disposition presently unknown.

Event 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.

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.

Event 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.

• Brand Name: CARBOMEDICS TOP HAT PROSTHETIC HEART VALVE, AORTIC
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 9926212
• MDR Text Key: 191914630
• Report Number: 3005687633-2020-00114
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)191117
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 50 YR