MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/11/2022

Event Type  Injury  

Event Description

Valve was loaded incorrectly outside the body, therefore, deployment device in a reverse orientation causing hemodynamic collapse requiring expert cpr and rapid intubation which was accomplished successfully.The proceduralists were able to quickly gain right femoral artery access and deploy a second valve, restoring normal circulation.Patient was transported to the cicu and was extubated later in the day with no neurological or physical deficits.Device is extremely reliant on human factors and has high chance for error.Possible design update? you should not be able to load valves both directions.Create a hard stop.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 14851341
• MDR Text Key: 294924511
• Report Number: 14851341
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX26
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention