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

Model Number 9750TFX26A

Device Problem Perivalvular Leak (1457)

Patient Problem Hemolysis (1886)

Event Date 07/12/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The device remains implanted.

Event Description

As reported by a field clinical specialist (fcs), approximately 6 months and 29 days post-implant of a 26 mm sapien 3 ultra valve in the native aortic valve via transfemoral approach, the patient came back with moderate to severe pvl and hemolytic anemia with symptom of short of breath.Today, the team tried to treat the patient with dilating existing tavr valve with 26mm commander delivery system balloon 1st.There was still moderate ai noted after post-dilation.The patient was treated with 26 mm s3 ultra valve.Patient was stable after tavr.There was no edwards device malfunction or premature failure.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: added new information to h.6 type of investigation, investigation findings and investigation conclusions.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 unable to be confirmed as no medical record or relevant imagery provided for evaluation.A review of the dhr did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of the ifu and training manuals revealed no deficiencies.Per the instructions for use (ifu), paravalvular leak (pvl) is a 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.As reported, ''approximately 6 months and 29 days post-implant of a 26 mm sapien 3 ultra valve in the native aortic valve via transfemoral approach, the patient came back with moderate to severe pvl and hemolytic anemia with symptom of short of breath.Today, the team tried to treat the patient with dilating existing tavr valve with 26mm commander delivery system balloon 1st.There was still moderate ai noted after post-dilation.The patient was treated with 26 mm s3 ultra valve''.Due to limited information and unavailability of relevant imagery/ returned product, a definite root cause is unable to be determined at this time.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.There were no allegation or indication of an edwards' device malfunction.These events are covered under fda thv/tvt registry exemption e2016006 and will be reported via edwards summary reporting.

• 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: 15176687
• MDR Text Key: 297353688
• Report Number: 2015691-2022-07201
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)230531
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 9750TFX26A
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2021
• 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 Sex: Male