MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARDIO SENSOR DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Device Problem Failure to Advance (2524)

Patient Problem Failure of Implant (1924)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

During cardiomems implant procedure the physician was unable to advance the sensor delivery system past the patient's tricuspid valve (evoque tricuspid valve made by edwards).The procedure was abandoned and there were no adverse consequences to the patient.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CARDIO SENSOR DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES
• MDR Report Key: 17488379
• MDR Text Key: 320706696
• Report Number: MW5121078
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1