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

Model Number 9600TFX29A

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Insufficient Information (4580)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), valve malposition and embolization are known potential complications associated with the transcatheter valve replacement (tvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve malposition/embolization, including, but not limited to, improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, loss of pacing capture, rapid deployment and movement of the delivery system by the operator.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 thv.The patient screening manual instructs the operator on proper aortic valve and root assessment, including the use of echo, cine and ct to appropriately measure landing zone, content and distribution of calcium, and leaflet characteristics.Contraindications, important considerations when assessing the valve, and choosing the proper thv are also discussed.The thv training manuals also instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures are also included.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.As reported, during deployment, the implanter inflated too quickly the commander delivery system and the 29mm sapien 3 valve jumped ventricular.The root cause of the event was likely due to procedure related factors(technique).Post case, there was a discussion with implanter on inflation technique during valve deployment.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.

Event Description

Edwards received notification from a field clinical specialist that during a transfemoral venous with transeptal puncture tmvr valve in valve (thv in non-edwards surgical), a 29mm sapien 3 (s3) valve final position was too ventricular with severe mitral regurgitation (mr) and a second s3 valve was implanted.As reported, during deployment, the implanter inflated too quickly the commander delivery system and the 29mm s3 jumped ventricular.Initially, the valve was partially anchored within the 33mm non-edwards surgical valve.Severe mitral regurgitation (mr) was seen on tee.As soon as the delivery system was removed from across the s3, the valve embolized down onto the safari wire.Medication was given to increase the blood pressure and the valve moved back up and lodged itself into the surgical valve posts.A second 29mm s3 was deployed within the surgical valve and s3 valve, successfully anchoring the first implanted s3 valve in place.Tee revealed no paravalvular (pvl), no central leak, a low gradient, and 2 sets of functioning leaflets.The patient remained stable throughout the entire procedure.The delivery system was prepped with +5cc added to the nominal volume.

Manufacturer Narrative

Supplemental report submitted to include additional information received through follow-up.Updated h6.It was clarified that the mitral regurgitation was due to the malposition of the first s3 valve implanted.Post deployment the s3 valve was canted inside of the surgical mitral valve which appeared to pin the leaflets open and not allowing them to adequately coapt.Per the instructions for use (ifu), central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (tvr) 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.All of these factors have the potential to contribute to suboptimal coaptation of the sapien 3 valve leaflets and cause central regurgitation.Occasionally there are cases where the root cause of the regurgitation cannot be determined.

Manufacturer Narrative

Edwards reviewed the article ''ventricular embolization of mitral valve in valve rescued with a second valve" tanush gupta md, and sachin s.Goel md et.Al.Published in j invasive cardiol, 2023;35(1):e55-e56.It was found that the article pertained to this case.Supplemental report submitted to include additional information received.Updated a2 and b7.

• 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: 12316459
• MDR Text Key: 266372368
• Report Number: 2015691-2021-04654
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)220218
• 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,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: 9600TFX29A
• Device Catalogue Number: N/A
• Device Lot Number: 7331907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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
• Patient Age: 89 YR
• Patient Sex: Male