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

Model Number 9750TFX26A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Unspecified Infection (1930)

Event Date 12/29/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The valve was not returned for evaluation.

Event Description

As reported by implant patient registry, approximately 2 months and 24 days post tavr procedure with a 26mm sapien 3 ultra valve in the aortic position the valve was explanted due to unknown reasons.An edwards surgical valve was implanted.Per the field clinical specialist, a relative reported the valve was explanted because the patient had a blood infection.The patient had ankle surgery prior to tavr procedure then had to do a mitral valve replacement.Investigation is ongoing.

Manufacturer Narrative

Per clinical review of the medical records, the valve was explanted approximately 2 months and 24 days post tavr procedure due to late endocarditis with positive blood cultures for enterococcus faecalis.Late endocarditis occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the body and is not in any way related to the sterilization or packaging process of the device.Based on these results, this complaint is no longer considered to be a reportable event and a corrected report is being submitted.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
• 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: 16294980
• MDR Text Key: 308762462
• Report Number: 2015691-2023-10567
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)250409
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX26A
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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 Age: 68 YR
• Patient Sex: Male