MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 UTRA TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26

Device Problems Material Twisted/Bent (2981); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards affiliate in the united kingdom, during a transfemoral tavr procedure, the 26mm sapien 3 ultra valve/commander delivery system became stuck inside the 14fr esheath.With high forces, the delivery system was advanced further through the esheath but caused the strut of the 26mm sapien 3 valve to become bent.Both the delivery system and esheath were removed as a unit.The patient was noted to be doing well and was discharged home on pod1.

Manufacturer Narrative

Examination of the returned device confirmed the strut had a very slight bent strut with no damage to the esheath.Therefore, the risk of a vascular injury is remote.This event is considered not reportable.

• Brand Name: EDWARDS SAPIEN 3 UTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10203947
• MDR Text Key: 197568582
• Report Number: 2015691-2020-12326
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2022
• Device Model Number: 9750TFX26
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1