MAUDE Adverse Event Report: EDWARDS LIFESCIENCES US S3 UR VALVE 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9755RSL26A

Device Problems Incomplete Coaptation (2507); Central Regurgitation (4068)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.H3 other text : remains implanted.

Event Description

As reported by a field clinical specialist, a patient underwent a transfemoral tavr procedure with a 26mm sapien 3 ultra resilia valve in aortic position.The valve size was in between 26mm and 29mm so the physician went with a larger sheath to avoid a sheath exchange.The first valve was deployed and there was central leak due to a leaflet not functioning properly and not co-apting.A second 26mm sapien 3 ultra resilia valve was needed because of the ai and implanted inside the initial valve.

• Brand Name: US S3 UR VALVE 26MM
• 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: 18872379
• MDR Text Key: 337292032
• Report Number: 2015691-2024-01921
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)260716(11)230717
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9755RSL26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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