MAUDE Adverse Event Report: LIVANOVA CANADA CORP CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number CPHV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/11/2018

Event Type  Death  

Manufacturer Narrative

Based on the information received from the site the event is reasonably attributable to the procedure and no device malfunctions have been identified.In addition there was a clear mis-sizing of the device reported leading to an intra-operative explant and replacement of the device.Because no further information is available and the device will not be received no further investigations will be performed.If further information is received the case will be reassessed.The manufacturer is reporting in a conservative manner due to the young age of the patient at the time of death and the lack of information available.This report regards the mis-sizing leading to intra-operative explant.A second report has been filed ((b)(4)) regarding the replacement valve that was still implanted at the time of death.

Event Description

A patient was diagnosed pulmonary atresia with vsp and received a repair on (b)(6) 2018.Due to complications the patient had 2nd and third surgeries on (b)(6) and (b)(6) respectively.On (b)(6) the patient received a carbomedics top hat s5-019 mechanical heart valve and a coronary bypass was performed.Due to issues with the patient's response the s5-019 was explanted and replaced with a smaller carbomedics standard for small annuli a5-016.The patient passed away on (b)(6) 2018.The operations note did not identify the device was available for analysis.Site noted no further information available due to the patient being a minor.This report regards the carbomedics top hat s5-019 mechanical heart valve that was explanted intra-operatively.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: strada crescentino snc; saluggia, vc 13040
• MDR Report Key: 7980279
• MDR Text Key: 124193921
• Report Number: 3005687633-2018-00198
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2021
• Device Model Number: CPHV
• Device Catalogue Number: S5-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 7 YR