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

Model Number 9750TFX26A

Device Problems Fluid/Blood Leak (1250); Unintended Collision (1429); Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 01/19/2023

Event Type  Injury  

Event Description

As reported by the field clinical specialist, approximately 6 months, 22 days post tmvr procedure with a 26mm sapien 3 ultra valve in a surgical ring, the valve presents paravalvular leak (pvl).While treating the pvl with a plug, the ventricular disc was 'inside' the sapien 3 valve, interfering with the leaflet and slightly worsening central.It was decided to perform a valve in valve (vinv) procedure with a 26mm sapien 3 valve.

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist, approximately 6 months, 22 days post tmvr procedure with a 26mm sapien 3 ultra valve in a surgical ring, the patient presented with shortness of breath, and anemia.The valve presents paravalvular leak (pvl) due to high deployment.While treating the pvl with a plug, the wire 'could not stay out of the s3 valve', and it entered the open cell and then into lv.Through a 8fr torqvue sheath, the team deployed a plug in the pvl.However, the ventricular disc was 'inside' s3 valve interfering with the leaflet and slightly worsening central mitral regurgitation.However, pvl was completely gone.It was decided to perform a valve in valve (vinv) procedure with a 26mm sapien 3 valve with nominal +4 cc prep.Per procedural information obtained from salesforce, the final valve position post deployment was 90/10 (ao/lv) and the valve was post-dilated due to pvl as seen on tee.

Manufacturer Narrative

Correction to h6 based on additional information.The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaints for deployed valve exhibits central regurgitation, interventional device interacts with non-edwards device, malpositioned thv, and paravalvular leak were unable to be confirmed as no medical record or imagery were provided.As reported, 'approximately 6 months, 22 days post tmvr procedure with a 26mm sapien 3 ultra valve in a surgical ring, the patient presented with shortness of breath, and anemia.The valve presents paravalvular leak (pvl) due to high deployment [90/10: a/v].While treating the pvl with a plug, the wire 'could not stay out of the s3 valve', and it entered the open cell and then into lv.Through a 8fr torqvue sheath, the team deployed a plug in the pvl.However, the ventricular disc was 'inside' s3 valve interfering with the leaflet and slightly worsening central mitral regurgitation'.Per ifu, valve malposition requiring intervention is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.In this case, it was reported that the valve was positioned 'high'; however, review of procedural information revealed the final valve position post deployment was 90/10 (ao/lv), which is within the recommended position per training manual.Without further information or imagery, a root cause is unable to be determined at this time.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.While the field perceived malposition (high deployment) contributed to the reported event; there is insufficient evidence provided to confirm the causality of the event.The valve was deployed at 90:10 (a/v) position, which is within ew recommended position.In this case, the valve was deployed inside a pre-existing mitral ring.The mitral ring is typically non-circular in shape (c or d-shaped).Deploying a circular valve (s3u) inside a non-circular ring may create a gap leading to pvl.While a definitive root cause was unknown, it is possible that patient factors (pre-existing ring shape) may have contributed to the reported event.As reported, while treating the pvl with a plug, the wire 'could not stay out of the s3 valve', and it entered the open cell and then into lv.The team proceeded with deployed the plug in the pvl; however, the ventricular disc was 'inside' s3 valve interfering with the leaflet and slightly worsening central mitral regurgitation.Based on provided information, the negative interaction between the plug and valve can be attributed to procedural factors (guidewire mismanagement).In this case, the plug used to treat the reported pvl interacted with the pre-existing valve and resulted in central mitral regurgitation.As such, available information suggests that procedural factors (non-edwards device interaction) may have contributed to the complaint event.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.

• Brand Name: SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: MITRAL VALVE, PROSTHESIS, 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: 16380927
• MDR Text Key: 309599408
• Report Number: 2015691-2023-10824
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)250309
• 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
• Report Date: 03/27/2023

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 Model Number: 9750TFX26A
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2022
• 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