MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE; 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); Insufficient Information (4580)

Event Date 01/27/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The device is not returning.

Event Description

As reported by implant patient registry, approximately 1 year and 5 months, post-implantation of a 26 mm sapien 3 ultra valve in the aortic position via transfemoral approach, the 26 mm sapien 3 valve was explanted, and an edwards surgical valve was implanted.The reason for the explant is unknown at this time.

Manufacturer Narrative

A supplemental mdr is being submitted for correction base on the review of the medical records.The following sections of this report have been updated: corrected h.6 clinical code, device code, type of investigation, investigation findings, and investigation conclusions.It was initially reported that approximately 1 year and 5 months, post-implantation of a 26 mm sapien 3 ultra valve in the aortic position via transfemoral approach, the 26 mm sapien 3 valve was explanted, and an edwards surgical valve was implanted.Per the medical records, the explant was related to endocarditis and there was no allegation of an edwards device caused or contributed to the endocarditis.It should be noted that the blood cultures were positive for strep mitis/oral streptococcus viridans of unknown etiology.Late endocarditis greater than 60 days 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.Per the instructions for use (ifu), infection including septicemia and endocarditis, is a potential adverse event associated with aortic valve replacement.Endocarditis is an infection of a native or prosthetic valve, is treated with antibiotics, and may require valve replacement if antibiotic therapy is not effective.Causes of prosthetic valve endocarditis are well documented in the literature and are typically classified as early (<60 days) or late (>60 days).Late prosthetic valve endocarditis is usually caused by an infection which occurs elsewhere in the body, and then seeds the valve.The most frequent causes are dental procedures, urological infections, invasive interventions, and indwelling catheters.Edwards lifesciences produces and provides sterile tissue bioprostheses to its customers by following carefully designed robust sterilization processes.These manufacturing processes have been validated and demonstrated to consistently provide a significant safety factor from which microorganisms could not survive.Microbiology and process monitoring is routinely reviewed within quality systems to maintain sterility control.Validated testing has demonstrated that microorganisms could not survive edwards' multi-stage processing with enhanced sterilant or heated glutaraldehyde terminal sterilant solution.These multiple, redundant manufacturing controls ensure the sterility of edwards' valves as provided to customers.Therefore, the probability of endocarditis related to edwards' bioprostheses is remote.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.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
• 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: 16452809
• MDR Text Key: 310344714
• Report Number: 2015691-2023-11144
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)230510
• 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,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: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2023
• 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: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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: Female