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

Model Number 9750TFX26A

Device Problem Material Integrity Problem (2978)

Patient Problems Rupture (2208); Obstruction/Occlusion (2422)

Event Date 06/29/2022

Event Type  Death  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral transcatheter valve replacement procedure in the native mitral position with lampoon and a 26mm sapien 3 ultra valve, the patient's left ventricular outflow tract obstruction (lvot) gradient was > 40 post valve deployment.The valve was manipulated in an attempt to reduce the lvot gradient, and a 26mm z med balloon was used to dilate the lvot.This compromised the stent integrity of the sapien 3 valve, and the large cells of the frame were damaged.The patient develop a pericardial effusion observed by tee, and likely 'some type of rupture'.As the patient was not a surgical candidate, the decision was made to withdraw care due to no transcatheter options being available for intervention.The patient passed away on the table.

Manufacturer Narrative

It should be noted that sapien 3 ultra was implanted in native mitral position for this case.The sapien 3 ultra (s3u) with the commander delivery system (ds) was indicated for native aortic valve replacement, surgical or transcatheter bioprosthetic aortic valve replacement, surgical bioprosthetic mitral or pulmonic valve replacement, a native mitral valve with an annuloplasty ring, or a rvot conduit in pulmonic position.Therefore, this case is considered off-label operation the ifu and training manuals in this section are for transfemoral procedure in aortic/mitral position and was reviewed for relevant guidance for an s3u implant using a commander delivery system.Based on this review, there were no ifu/training deficiencies were identified.The complaints for interventional device interacts with non-edwards device, valve damage, and malpositioned thv were unable to be confirmed as relevant imagery/medical record was not provided for evaluation.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.It should be noted that the s3u valve was implanted in native mitral position, which is not indicated for use.Therefore, this case is considered off-label.As reported, 'a 26mm z-med balloon was used to dilate the lvot.This compromised the stent integrity of the sapien 3 valve, and the large cells of the frame were damaged.The patient develop a pericardial effusion observed by tee, and likely 'some type of rupture'.As the patient was not a surgical candidate, the decision was made to withdraw care due to no transcatheter options being available for intervention.The patient passed away on the table.Per report, it is believed that bav caused damage to the leaflets of the thv.The valve was not necessarily malpositioned.However, it was too deep and caused a significant lvot gradient.The damage done by the balloon from the lvot compromised the large cells of the valve.' there are multiple patient and procedural factors that alone or in combination can cause or contribute to malposition, including improper positioning before deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified leaflets, preserved ejection fraction, significant annular calcification, loss of pacing capture, rapid deployment, the release of stored tension during deployment, and movement of the delivery system by the operator.In this case, the thv was implanted in native mitral mac, which is not indicated for use.It is possible that procedural factors (off-label operation) may have contributed to the reported event.However, a definitive root cause is unable to be determined.As reported, a z-med balloon (non-compliant balloon) was used to post-dilate lvot (left ventricle outflow tract), and it was intended to pull back the deployed valve toward more atrial due to the malposition and increased gradient.In this case, it was possible excessive manipulation, which led to the valve damage from the interaction between valve and non-compliant balloon.As such, available information suggests that procedural factors (thv malpositioned, excessive manipulation, off-label operation) may have contributed to the reported event.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 ULTRA TRANSCATHETER HEART 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: 15113280
• MDR Text Key: 296689003
• Report Number: 2015691-2022-07032
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)231110
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: 9750TFX26A
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention