MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER, 23MM; AORTIC VALVE PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endocarditis (1834)

Event Date 01/06/2023

Event Type  Injury  

Event Description

As reported by our europe affiliate, approximately 1 month post implant of a 23mm sapien 3 valve in aortic position, blood cultures were performed due to increased cpr and blood cultures and enterococcus faecalis was noted.The patient was treated with antibiotics.Patient was suspected to present endocarditis.Of note, the patient was discharged on post-operative day 3 (pod3) with no reported complications.The patient's bicuspid aortic valve measures 19mm, with an average gradient of 40.

Manufacturer Narrative

Per the instructions for use (ifu), infections such as septicemia and endocarditis are known potential adverse events associated with the thv procedure.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 (less than 60 days) or late (greater than 60 days).The two categories show definite differences in clinical features, microbial patterns, and mortality.Early prosthetic valve endocarditis is usually caused by perioperative bacterial contamination of the valve.In early cases of prosthetic endocarditis, subsequent infections are almost universally related to contamination at the time of surgery.If there were ever non-conformances in the sterility or packaging processes, they would most likely manifest in the early post-operative period.Considering this, only reports of prosthetic endocarditis occurring within 60 days of implant, without a known source of infection, would be mdr reportable.According to the literature review, and as documented in a technical summary written by ew, early prosthetic valve endocarditis occurring within 60 days of valve implantation generally reflects contamination arising in the perioperative period.There are many opportunities for organisms to seed a prosthesis perioperatively, most contamination probably occurs intraoperatively.Edwards lifesciences produces and provides sterile tissue bioprosthesis 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' bioprosthesis is remote.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate patient factors (ckd, lymphoma treated with chemotherapy) caused or contributed to this event.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

Manufacturer Narrative

Per the initial report, approximately 1 month post implant of a 23mm sapien 3 valve in aortic position, blood cultures were performed due to increased cpr and blood cultures and enterococcus faecalis was noted.The patient was treated with antibiotics.Additional information received, as per sterilization information review documented by an edwards microbiologist indicates that the microorganism identified in the endocarditis event could not survive in edwards' multistage solution processing or terminal sterilant solution and is rapidly inactivated.Edwards lifesciences provides sterile tissue bioprostheses to customers with carefully designed robust sterilization processes for which the efficacy has been demonstrated consistently and which provide a significant safety factor.It can be concluded that the bioprosthetic valve, as supplied by edwards lifesciences, would not be the source of infection.In this case, investigation results suggest aortic valve endocarditis was not caused or contributed to the sapien 3 valve.There was no allegation or indication an ew product malfunction caused or contributed to this adverse event.Based on this finding, this event is no longer considered to be fda reportable.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER, 23MM
• 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: 16281055
• MDR Text Key: 308607610
• Report Number: 2015691-2023-10486
• Device Sequence Number: 1
• Product Code: NPT
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2023
• 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): Other
• Patient Age: 79 YR
• Patient Sex: Female