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

Model Number 9600TFX20J

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Heart Block (4444); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/14/2022

Event Type  Death  

Manufacturer Narrative

Per the instructions for use (ifu), conduction system defects (heart block), arrhythmias and conduction system defects that may require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, bioprosthetic heart valves, and the thv procedure.According to the valve academic research consortium (varc) guidelines, the close anatomical relationship between the aortic valve complex and the branching atrioventricular bundle may explain these complications of the thv procedure.According to the literature review, and as documented in ew clinical technical summary for complaints-conduction disturbances/ heart block, atrioventricular conduction disturbances after thv are associated with many patient-related and procedural related factors, including pre-operative co-morbid status, the degree, and bulkiness of aortic valve and annular calcification, inter-ventricular septal thickness, pre-existing electrocardiogram abnormalities, the depth of prosthesis implantation, and the profile of the implanted prosthesis.Unlike conventional avr, where there may be localized trauma due to decalcification of the annulus and/or suture placement in the proximity of the av node or the bundles, thv may cause conduction abnormalities through mechanical impingement of the conduction system by the prosthesis.The mechanisms of the development of heart block after thv are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing thv or surgical avr and another 4-6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.With the limited information available, the exact cause of the heart block is unknown but may be related to the mechanisms above.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.Per the instructions for use (ifu), infections such as septicemia are known potential adverse events associated with the thv procedure.Sepsis is a condition in which a patient meets criteria for sirs (systemic inflammatory response syndrome) and has a known or highly suspected infection.The mortality rate is high if the sepsis is not treated and can progress to involve organ failure (severe sepsis).While any type of infection - bacterial, viral or fungal - can lead to sepsis, infections that more commonly result in sepsis include infections of: lungs, such as pneumonia, urinary system, digestive system, bloodstream (bacteremia), catheter sites, and wounds or burns.Several factors increase the risk of sepsis, including: older age, compromised immune system, diabetes, chronic kidney or liver disease, admission to intensive care unit or longer hospital stays, invasive devices, (such as intravenous catheters or breathing tubes) and previous use of antibiotics or corticosteroids.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 are inconclusive as limited information was provided.Additional details regarding the event (i.E., source of infection, patient comorbidities, procedural factors) are not available.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.Mitral regurgitation in thv procedures can occur from chordae tendinae entrapment during advancement of the guidewire, bav catheter, or delivery system.This can result in transient mitral insufficiency which may resolve upon removal of the devices.Per the instructions for use (ifu), valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (tvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve regurgitation including, but not limited to, malposition of the valve, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, a severely elliptical annulus shape, valve under-sizing.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.The patient screening manual instructs the operator on proper native valve leaflet assessment, taking into consideration the length, bulkiness and distribution of calcium on the native leaflets to determine whether valve performance will be impaired.In this case, there was no allegation or indication a product deficiency contributed to this adverse event.The cause of the mitral regurgitation cannot be confirmed, however, may be related to anatomical patient/procedural factors.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 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.H3 other text : the device remained implanted in the patient.

Event Description

As reported by our edwards lifesciences japanese affiliate and through the japanese post-marketing surveillance system, the patient developed heart block, mitral regurgitation, and septic shock from bacteremia.A 20 mm sapien 3 valve was implanted in the aortic position via transfemoral approach.After valve deployment, heart block developed, and the patient returned to the icu with temporary pacing.A permanent pacemaker was scheduled to be implanted.However, the pacemaker was not implanted due to bacteremia on post operative day 1.It was also reported that the patient developed heart failure due to increase of native mitral regurgitation and septic shock from bacteremia.On post operative day 3, the patient expired.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on new information received through investigation as well as the device evaluation.The following sections of this report have been updated: corrected b1, additional information added to b5, code added to h6 device code, code removed from h6 health effect clinical code, code added to h6 health effect clinical code, code added to h6 device codes, code added to h6 type of investigation, code corrected in investigation findings, additional information added to h10.Through investigation, it was learned that physician attributed the mitral regurgitation to the pacemaker-dependent rhythm.As such, the h6 health effect clinical code 'mitral valve insufficiency/ regurgitation' was removed.The sapien 3 valve was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was not provided for review.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.The instructions for use/training manuals were reviewed for guidance/instruction involving the sapien 3 valve usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of the risk management documentation was performed, and the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The event of aortic regurgitation was unable to be confirmed.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.Per the instructions for use (ifu), valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve regurgitation including, but not limited to, malposition of the valve, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, a severely elliptical annulus shape, valve under-sizing.Due to limited information, a definitive root cause was unable to be determined at this time.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

Event Description

Additional information was received through our edwards lifesciences japanese affiliate.Immediately after deployment of the 20 mm sapien 3 valve, mild aortic regurgitation developed.Aortic regurgitation increased to mild-moderate while the patient was in the icu.The physician considered that mitral regurgitation (associated with pacemaker-dependent rhythm and not the edwards device) and aortic regurgitation may have placed a significant burden on the hemodynamics during the perioperative period.

• Brand Name: SAPIEN 3 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: 16401998
• MDR Text Key: 309857669
• Report Number: 2015691-2023-10958
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103195026
• UDI-Public: (01)00690103195026(17)240417
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX20J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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): Death; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female