MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SAPIEN 3 ULTRA SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM26

Device Problems Fracture (1260); Difficult to Remove (1528); Material Rupture (1546); Activation, Positioning or Separation Problem (2906)

Patient Problem Vascular Dissection (3160)

Event Date 06/22/2023

Event Type  Death  

Event Description

During deployment of transcatheter aortic valve replacement (tavr) valve, valve balloon ruptured.Balloon was difficult to remove and caused fracture of deployment system and wire.Once balloon and sheath were removed, it was noted that there was part of the patient's iliac artery was retained on the sheath.

• Brand Name: SAPIEN 3 ULTRA SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 17236543
• MDR Text Key: 318212631
• Report Number: 17236543
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/28/2023,06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 64932795
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 31755 DA
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: Black Or African American