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

Model Number 9755RSL29A

Device Problem Material Deformation (2976)

Patient Problem Vascular Dissection (3160)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

During pre-decontamination evaluation of the returned devices, it was observed that two valve struts of the first 29mm sapien 3 ultra resilia were bent outward on the inflow side.As reported by an edwards lifesciences field clinical specialist, patient underwent left carotid approach via surgical cutdown for a transcatheter aortic valve replacement procedure with a 29mm sapien 3 ultra resilia.Utilizing a 16fr esheath+ and 29mm commander delivery system, the valve was noted to buckle/dive in the sheath shaft, requiring removal of the system.The valve was exiting the out of the side of the sheath via a puncture in the liner.The devices were removed as a unit.A new system was prepped, and a new 29mm sapien 3 ultra resilia was successfully delivered.At the end of the procedure upon access site closure a left carotid artery dissection was noted.The dissection required graft and stenting.Procedure was performed successfully, and the patient was transferred in stable condition out of the or.During pre-decontamination evaluation of the returned devices, it was observed that two valve struts were bent outward on the inflow side.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 19140274
• MDR Text Key: 340561857
• Report Number: 2015691-2024-02988
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215823
• UDI-Public: (01)00690103215823(17)260712(11)230713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9755RSL29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male