MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29A

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Regurgitation (2259)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

Approximately 51 days post implantation of a 29mm sapien 3 valve inside a non-edwards bioprosthesis valve in the pulmonic position, the patient presented with moderate pulmonary regurgitation and mild pulmonary stenosis.Treatment is planned to either dilate with a 28mm balloon valvuloplasty (bav) catheter or perform a valve in valve procedure.As reported, the initial sapien 3 procedure went well.A high pressure bav catheter was used to crack the existing bioprosthesis valve.The sapien 3 valve was deployed in good position.An undetermined very mild paravalvular leak (pvl) and/or central regurgitation was noted.As described the 1st valve appeared ¿waisting¿ (flared out on top and bottom and smaller in the middle).The final valve position was acceptable.A 26mm size valve was recommended but a decision was made to place a 29mm valve.

Manufacturer Narrative

The edwards sapien 3 thv is currently under investigation in the united states for pulmonic application.Per the pulmonic ifu, the edwards commander delivery system and accessories are indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions: dysfunctional rvot conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention, and: regurgitation: = moderate regurgitation, and/or stenosis: mean rvot gradient = 35 mmhg.Per the instructions for use, valve dysfunction resulting in pulmonary valve symptoms is a potential risk associated with the use of the thv.According to the ifu and training manuals, correct sizing of the thv into the non-compliant rvot conduit or failing bioprosthesis is essential to minimize risks.Overall assessment and actual internal dimensions of the preexisting bioprosthetic valve are critical.Too small of a valve may result in paravalvular leak, migration, or valve embolization; whereas too large of a valve may result in residual gradient (patient-prosthesis mismatch) or rvot rupture.Factors such as calcification and pannus tissue growth may not be accurately visualized in imaging and may reduce the effective inner diameter of the failing bioprosthesis to a size smaller than the ¿true id¿.These factors should be considered and assessed in order to determine the most appropriate thv size to achieve nominal thv deployment and sufficient anchoring.The dimensions of the failed bioprosthesis should be determined so that the appropriate thv size can be implanted; and is best determined by using balloon sizing and/or computed tomography to perform the necessary measurements.Surgical valve ¿true id¿ may be smaller than the labeled valve size.For thv-in-surgical valve procedures, size recommendations for the existing bioprosthesis true inner diameter (true id) are listed in the ifu.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.The thv procedural training manual instructs the operator on proper assessment of the failed bioprosthesis where the thv will be implanted, taking into consideration the valve type, labeled valve size (id and true id), fluoroscopically visible components, and structural valve deterioration (calcification, leaflet thickness, presence of pannus and leaflet disruption).The device remains implanted in the patient.In this case, the cause for the worsening regurgitation of the 29mm sapien 3 valve could not be confirmed; however, it appears that valve oversizing may have contributed to the event.As reported, the patient had a stenotic non-edwards 25mm surgical bioprosthesis, which is more consistent with a 26mm sapien 3 valve.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No corrective or preventative actions are required.

Manufacturer Narrative

Additional information was provided by the facility nurse (including partial echocardiogram reports): from the post-operative day (pod) 1 echo report, it appeared that there was mild pvl and moderate pulmonic valve insufficiency (pi).No pulmonary valve stenosis, peak gradient 21 mmhg, mean gradient 13 mmhg.Echo on pod-18 reported that the pi had improved, with mild pvl degree, unchanged.Semi-lunar valves: at least two jets of insufficiency seen through the bioprosthetic valve.One jet appears to be eccentric through the valve and the second jet appears to be paravalvular.Investigation is ongoing.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

Manufacturer Narrative

An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect (common device name, product code, pma number, or other missed or incorrect information).A correction to fields d2 is being submitted in this supplemental report.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 7792206
• MDR Text Key: 117423226
• Report Number: 2015691-2018-03413
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2019
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2018
• 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: 13 YR
• Patient Sex: Male