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

Model Number 9600TFX23A

Device Problems Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Death (1802); Endocarditis (1834); Fever (1858); Pain (1994); Vomiting (2144); Regurgitation (2259); Dysuria (2684)

Event Date 06/09/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As found though an on-line obituary search conducted by the edwards lifesciences implant patient registry, the patient expired 34 days post implant of a 23mm sapien 3 valve.Medical record review revealed the patient underwent a successful, uncomplicated tavr procedure via right side transfemoral approach.Following bav with an edwards 16mm balloon, a sapien 3 valve was advanced and deployed in the intended position.Post deployment no aortic regurgitation was observed and the procedure was completed.The patient tolerated the procedure well and was transferred to the post-anesthesia care unit in stable condition.She received post tavr antibiotic propylaxis with iv vancomycin and cefazolin.No device malfunctions or adverse events were reported.Post tavr echo showed prosthetic aortic valve well seated, with peak gradient 23 mmhg, mean gradient 13 mmhg, and no central or paravalvular leak.The patient was discharged on postoperative day (pod) 2.On pod10, the patient presented with fevers, emesis, dysuria and flank pains, and was found to have pseudomonas bacteremia initially thought to be secondary to a urinary source.The patient was readmitted and started on antibiotic treatment and initially improved but became febrile again on pod13.Blood cultures were still positive for pseudomonas bacteremia.Tte indicated a well seated valve with trace regurgitation.On pod16, the patient was transferred to the tavr facility for evaluation and management of persistent intermittent fevers and high grade bacteremia.Tee showed no evidence of endocarditis.Despite extensive work-up, the source of the infection could not be determined.Even though tte/tee showed no evidence of vegetation on valves or icd leads, due to the persistent positive blood cultures, the decision was made to treat the patient as if she had prosthetic valve endocarditis.The patient was started on a 6-week course of antibiotics and discharged on pod25.On pod31, the patient was transferred from her skilled nursing facility (snf) due to altered mental status and positive blood cultures, and readmitted.Blood cultures were positive for pseudomonas.On arrival, the patient was unresponsive and not following commands.Tee showed a mobile echodensity on the aortic valve.The patient¿s condition (continued bacteremia, despite antibiotic treatment, worsening clinical status and inability to undergo surgical removal of the infected valve) was discussed with the patient¿s family.The patient was placed on comfort care and peacefully passed away on pod34.

Manufacturer Narrative

Thv/tvt registry.The valve remains in the patient and therefore not available for evaluation.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).Early prosthetic valve endocarditis is usually caused by perioperative bacterial contamination of the valve.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.As noted, lot numbers for valve complaints reference the valve serial number only.Therefore, the lot history review was performed by taking the valve serial numbers (6498862 to 6498871) and verifying that there have been no other complaints associated with each serial number.The lot history review did not reveal any other complaints related to endocarditis.Device history review (dhr) review was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.In this case, there was no allegation or indication of a device malfunction.Although the source of the post tavr pseudomonas bacteremia infection could not be determined, due to the persistent positive blood cultures, the patient was treated as if she had prosthetic valve endocarditis.Unfortunately, despite the antibiotic treatment a mobile echodensity was observed on the implanted valve, contributing to the worsening clinical status and subsequent death.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8758155
• MDR Text Key: 149948067
• Report Number: 2015691-2019-02465
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 92 YR