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

Model Number 9600TFX29

Device Problems Fluid/Blood Leak (1250); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in canada, this was a case with a 29mm sapien 3 valve in aortic position by transfemoral approach.The valve was implanted about one millimeter too high, causing an aortic insufficiency.A second 29mm sapien 3 valve was implanted within the first valve to solve the problem.

Manufacturer Narrative

Updated h6-type of investigation, investigation findings, investigation conclusions.The device was not returned for evaluation as it remained implanted.The complaints for valve malposition and valve regurgitation were unable to be confirmed as no imagery /medical record were provided for evaluation.There was no allegation or indication a device malfunction contributed to this adverse event.A review of instructions for use (ifu )/training materials revealed no deficiencies.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure modes is not required at this time.As reported, "a 29mm sapien 3 valve was implanted about one millimeter too high, causing an aortic insufficiency." per the ifu, valve malposition requiring intervention is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to aortic malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified aortic leaflets, preserved ejection fraction, significant mitral annular calcification (mac), loss of pacing capture, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.Due to limited information, a definitive root cause for valve malposition was unable to be determined.Per the ifu, valve regurgitation (paravalvular or transvalvular/central) is a known potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (thv) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to central regurgitation including malposition of the valve, impingement of a leaflet due to the guide wire, over inflation of the deployment balloon, post-dilation of the implanted valve, and slow recovery of adequate ventricular flow post valve deployment and rapid pacing.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue.This type of leak can result from bulky annular calcification, improper thv sizing, malposition, or incomplete expansion.While a malpositioned valve is known to contribute to central regurgitation due to leaflet over-hang, this scenario can be ruled out in this case since it would be brought on by ventricular displacement as opposed to aortic.However, the high thv placement could have potentially prevented the pvl skirt from properly sealing against target site, resulting in paravalvular leak (pvl).As such, available information suggests that procedural factors (valve malposition) may have contributed to the valve regurgitation.However, a definitive root cause was unable to be determined.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 corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16418434
• MDR Text Key: 309983052
• Report Number: 2015691-2023-10985
• Device Sequence Number: 1
• Product Code: NPT
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 9600TFX29
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 78 YR
• Patient Sex: Male