MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26A

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Retroperitoneal Hemorrhage (4483)

Event Date 08/24/2021

Event Type  Death  

Event Description

Upon positioning a deployment balloon inside the sapien - edwards valve for a planned transcatheter aortic valve intervention, it was noted that a stent strut on the leading edge of the valve had been bent backwards after delivery to the descending aorta.It was decided that the best course of action was to remove the valve system and replace with a new one.Immediately after the withdrawal of the valve and sheath the patient became hypotensive.A large tear in the external iliac artery was noted.Although contralateral balloon tamponade and massive transfusion was performed the patient succumbed to a massive retroperitoneal bleed.Fda safety report id # (b)(4).

• Brand Name: EDWARDS SAPIEN VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC. ; irvine CA 92614
• MDR Report Key: 12391340
• MDR Text Key: 268908566
• Report Number: MW5103583
• Device Sequence Number: 1
• Product Code: NPT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: 9750TFX26A
• Device Lot Number: 7778836
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 91