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

Model Number 9300TFX26A

Device Problems Calcified (1077); Perivalvular Leak (1457)

Patient Problem Dyspnea (1816)

Event Date 01/17/2023

Event Type  Injury  

Event Description

As reported by a field clinical specialist (fcs) approximately 7 years and 7 months post transfemoral tavr procedure with a 26mm sapien xt in the aortic position, the patient now has elevated gradient/velocities with calcification and moderate paravalvular leak (pvl).The patient is symptomatic with shortness of breath.Per the fcs the team has discussed intervention with tavr and tavr.There is no case scheduled at this time.The valve gradient is 23mmhg /24.8mmhg, the velocity is 3.3 m/sec, and the area/index is 1.5cm2 / 0.9cm2/m2.Leaflet mobility is restricted and the leaflet is thickened and calcified.Per edwards physician proctor review of the transthoracic echocardiogram images provided by the site, the xt valve leaflets appear thickened and hypomobile.There is mild to moderate pvl between the right and left coronary cups.The calculated aortic valve area 1.2 cm2.It was noted that the original 26mm sapien xt was not fully expanded.

Manufacturer Narrative

The investigation is ongoing.The valve remains implanted.

Manufacturer Narrative

The device was not returned for evaluation.As the device was not returned, visual inspection, functional testing, and dimensional testing were unable to be done.The complaint for paravalvular leak was confirmed from imagery review.However, the complaint for calcification was unable to be confirmed as imagery review did not note calcification on leaflets.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of the ifu revealed no deficiencies.Per the instructions for use (ifu), paravalvular leak (pvl) is a known potential adverse event associated with bioprosthetic heart valves.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post-deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.In this case, imagery review revealed that there was mild to moderate pvl between the right and left coronary cusps, and the sapien xt valve was not fully expanded.Under-expanded valve may cause inadequate sealing between the valve skirt and the annulus, leading to pvl.It is also possible that the change in cardiac structure over time may have worsened the pvl.As such, available information suggests that patient factors (cardiac remodeling) and/or procedure factors (under-expanded valve) may have contributed to the reported paravalvular leak.An existing technical summary documents the root cause analysis on valve calcification over the time in patient.Per technical summary, calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent calcification from occurring in bioprosthetic valves.Furthermore, evaluation of reported complaints for ''valve - calcification'' and ''post implantation - svd - calcification'' did not confirm any manufacturing non-conformances and identified that the proper manufacturing mitigations have been implemented.Additionally, per technical summary, no evidence of a product non-conformance or device malfunction were found in any of the valves returned for these complaints.In this case, it was reported that the patient has a past medical history of chronic kidney disease (ckd) and dyslipidemia, which are well-known risk factors for bioprosthetic valve calcification.Calcified leaflet may appear thicken and can impact valve function by restricting leaflet movement, and thus leading to increased gradient.As such, available information suggests that patient factors (chronic kidney disease and dyslipidemia) may have contributed to the reported valve calcification.The device under investigation had been implanted for more than 5 years (implanted in (b)(6) 2015).There is no evidence of a design and/or manufacturing deficiency contributing to the reported event.Therefore, risk management file review is completed, no further action is needed.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.There were no ifu/training materials inadequacies or edwards defect identified.Therefore, no corrective or preventative actions nor product risk assessment (pra) is required.

• Brand Name: EDWARDS SAPIEN XT 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: 16342254
• MDR Text Key: 309259984
• Report Number: 2015691-2023-10708
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103192087
• UDI-Public: (01)00690103192087(17)170315
• 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: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2017
• Device Model Number: 9300TFX26A
• Device Catalogue Number: 9300TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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 Age: 87 YR