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

Model Number 9750TFX23A

Device Problem Perivalvular Leak (1457)

Patient Problems Dyspnea (1816); Hemolysis (1886)

Event Date 03/03/2022

Event Type  Injury  

Event Description

As reported by a field clinical specialist (fcs), approximately 1 year and 1 month post-implant of a 23 mm sapien 3 ultra valve in the native aortic valve via transfemoral approach, the patient is experiencing sob, fatigue, and hemolysis.The patient had a pvl closure procedure on (b)(6) 2022 and is being evaluated for another pvl closure procedure.

Manufacturer Narrative

The investigation is ongoing.The device remains implanted.

Manufacturer Narrative

The device 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 review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was confirmed based on medical report.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of device history record, lot history and complaint history did not reveal any indication of manufacturing nonconformance contributed to the reported event.In addition, review of ifu/training materials also revealed no deficiencies.As reported, ''approximately 1 year and 1 month post-implant of a 23 mm sapien 3 ultra valve in the native aortic valve via transfemoral approach, the patient is experiencing sob, fatigue, and hemolysis.'' per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valve and the transcatheter valve replacement procedure.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.Review of medical records revealed progressive valvular disease, as indicated by presence of severe mitral annular calcification and mild mitral stenosis in addition to aortic paravalvular leak.It is possible that the resulting heart disease had influenced the biomechanics of cardiac function, leading to morphological changes in the aortic valve, and thus, giving rise to the paravalvular leak.Additionally, more recent medical records indicated presence of dense annular calcium in aortic position, which likely contributed to the formation of pvl channels.As such, available information suggests that patient factors (cardiac remodeling, calcification) may have contributed to the complaint event.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 ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: EDWARDS SAPIEN 3 ULTRA 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: 15330539
• MDR Text Key: 299033820
• Report Number: 2015691-2022-07633
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)220827
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• 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: 10/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2020
• 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 Sex: Male