MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9300TFX26

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

Patient Problems Endocarditis (1834); Mitral Valve Stenosis (1965)

Event Date 01/12/2023

Event Type  Injury  

Event Description

As reported by a field clinical specialist, approximately 7 years after implantation of a 26mm sapien xt valve in a failing 25mm perimount mitral surgical valve, the sapien xt failed due to "stenosis due to endocarditis." a valve-in-valve-in-valve (viviv) procedure was performed.A 23mm sapien ultra resilia valve was successfully implanted within the 26mm sapient xt.It is unknown if the endocarditis infection was still active at the time of the viviv procedure.Additional information is not available at this time.

Manufacturer Narrative

The investigation is ongoing.The valve remains implanted.

Manufacturer Narrative

Per clinical review of the medical records, the valve was explanted approximately 7 years after implantation of a 26mm sapien xt valve in a failing 25mm perimount mitral surgical valve due to late endocarditis with blood cultures positive for streptococcus bacteremia secondary to skin cancer excision.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 XT TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 16308293
• MDR Text Key: 308895313
• Report Number: 2015691-2023-10611
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9300TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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