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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29MM PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
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.
 
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Brand NameEDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29MM
Type of DevicePULMONARY 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 Key7792206
MDR Text Key117423226
Report Number2015691-2018-03413
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/25/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/03/2019
Device Model Number9600TFX29A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/16/2018 Patient Sequence Number: 1
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