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

Model Number 9750TFX23A

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457)

Patient Problems Hemolysis (1886); Insufficient Information (4580)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

Thv/tvt registry.The investigation is ongoing.The valve remains implanted.

Event Description

As reported by the field clinical specialist, approximately 14 days post tavr procedure with a 23mm sapien 3 ultra valve in the aortic position, the patient presented with severe paravalvular leak (pvl) so the cardiologist decided to balloon with a 24 true balloon.After ballooning the patient had severe central leak.A valve in valve was performed a 26mm sapien 3 ultra valve in the aortic position.The 26mm sapien 3 ultra valve helped with central leak and a little with the pvl.Per the fcs the perceived root cause of the pvl was undersized valve choice.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The following section of this report has been updated:.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 complaints for paravalvular leak and central regurgitation were unable to be confirmed as no imagery/medical record was provided for evaluation.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could contribute to pvl, including device malposition, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, an elliptical annulus shape and valve under-sizing.In the case of pvl reported ''perceived root cause of the pvl was undersized valve choice.The patients native annulus area was measuring between sizing 23/26 per echo''.It was likely the undersized valve was selected, which would increase the risk of paravalvular leak over time due to inadequate sealed against to the target site (native annulus).In addition, it was noted that the patient had a bicuspid native valve.This could have posed a challenge to deploy the valve to create a seal against the target site (native annulus) due to the non-circular shape of landing zone and irregular contact between valve and target site also resulting in paravalvular leak.In the case of the central regurgitation, after post-dilation with 24mm true balloon the valve was likely over expanded from the post-dilation with bigger size of non-edwards balloon, which could prevent proper motion of the thv leaflets and lead to central regurgitation.As such, available information suggests that patient factors (biscupid native valve) and/or procedural factors (undersized valve) may have contributed to the paravalvular leak and procedural factors (post-dilation, over expanded valve) may have contributed to the central regurgitation.Since no product non-conformances or ifu or training deficiencies were identified during evaluation, neither a product risk assessment escalation, nor corrective or preventative actions are required.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.

Manufacturer Narrative

A supplemental mdr is being submitted based on additional information provided by the field clinical specialist.The following sections of this report have been updated: additional information b.5, g.3, g.6, h.2 and h.6 (updated clinical code to hemolysis).The investigation is ongoing.

Event Description

Per the field clinical specialist, the patient's native annulus area was measuring between sizing 23/26 per echo.Prior to the valve-in-valve procedure the patient was hemolyzing the valve.The site was not planning to treat the paravalvular leak and were happy with the end results.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
• 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: 16251115
• MDR Text Key: 308229511
• Report Number: 2015691-2023-10386
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)250526
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX23A
• Device Catalogue Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• 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): Required Intervention