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

Model Number 9600TFX29

Device Problems Perivalvular Leak (1457); Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 12/06/2021

Event Type  Injury  

Event Description

Edwards received notification from our affiliate in (b)(6).As reported, this was a case of an implant of 29mm edwards sapien 3 transcatheter heart valve in mitral position.2 months and 20 days post procedure, the patient returned with severe shortness of breath, and moderate paravalvular leak ( pvl) and improper leaflet coaptation was noted.A post dilation was performed, resulting in a minor improvement of the pvl.A valve-in-valve was aborted due to risk of left ventricular outflow tract (lvot) obstruction.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.

Manufacturer Narrative

The device was not returned for evaluation as it was remained implanted.Therefore, a no product return engineering evaluation was performed.No imagery was provided for review.The complaints of improper leaflet coaptation paravalvular leak were unable to be confirmed due to unavailability of returned device/relevant imagery.A review of the device history record (dhr) and lot history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.It should be noted that the thv was implanted in native mitral position for this case.The sapien 3 (s3) with the certitude delivery system (ds) was indicated for native aortic valve replacement only at the time of original implantation.While the device is now approved for surgical bioprosthetic aortic or mitral valve replacement, it remains off-label for native mitral valve replacement.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 , '2 months and 20 days post procedure, patient returned with severe shortness of breath, and moderate pvl and improper leaflet coaptation was seen.A post dilation was performed, resulting in a minor improvement of the pvl'.Additionally, the valve was directly deployed in native mitral annulus, which could potentially cause the valve migration over the time as reported due to mitral valve characteristics (absence of a solid anatomic structure to anchor the thv).Due to the potential of deployed valve migration, it is possible the pvl skirt could not properly seal against the native annulus or target site resulting in the paravalvular leak as reported.As such, available information suggests that procedural factors (off label operation (thv potentially migrated)) may have contributed to the complaint event.During the manufacturing process, all sapien 3 ultra 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 def ect or device malfunction contributed to the event.Due to the potential of thv migration , it is possible that the blood flow back pressure across the valve was no longer sufficient to support the coaptation of valve resulting in improper leaflet coaptation.As such, available information suggests that procedural factors (off label operation (thv potential migration)) may have contributed to the complaint event.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 the failure mode is not required at this time.Since no labeling or ifu/training inadequacies were identified; no corrective/preventive action nor product risk assessment (pra) is required.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.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 13084746
• MDR Text Key: 286673686
• Report Number: 2015691-2021-07067
• Device Sequence Number: 1
• Product Code: NPU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2022
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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