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

Model Number 9600TFX29A

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards field clinical specialist, during a transcatheter mitral valve replacement case, a 29mm sapien 3 system was prepped in accordance with the ifu and deployed to the mitral annulus.The valve started to migrate towards the atrium.The physician decided to deploy a second 29mm sapien 3 valve inside the first valve.During deployment, there were a few breakthrough beats that caused the second valve to be deployed more in the atrium than the physician initially wanted.After watching the patient and the valve for about ten minutes, the second valve started migrating towards the atrium and severe mitral regurgitation and paravalvular leak (pvl) were noted.A third 29mm sapien 3 valve was deployed.There was no mitral regurgitation and trace pvl.The patient was stable, and there was no harm to the patient.

Manufacturer Narrative

The device was not returned for evaluation as it remained implanted.The complaints valve malposition, valve migration, paravalvular leak, and central regurgitation were unable to be confirmed due to unavailable of relevant imagery and medical record.Review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.It should be noted that the valve was implanted in mitral position for this case, so it was an off-label operation.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure modes is not required at this time.As reported, "the valve started to migrate towards the atrium and the physician decided to deploy a second valve inside the first valve.During deployment, there were a few breakthrough beats that caused the second valve to be deployed more in the atrium than the physician initially wanted.After watching the patient and the valve for about 10 minutes, the second valve started migrating towards the atrium and severe mitral regurgitation and pvl were noted".The event description states, "there were a few breakthrough beats that caused the second valve to be deployed more in the atrium".Per training manual, "loss of capture during rapid pacing" can cause "sudden movement during deployment" leading to valve malposition.As such, available information suggests that procedural factors (loss of pacing capture) may have contributed to the malposition.Due to the second valve was deployed too atrium (malposition), which could lead to inadequate valve anchor onto target site (first valve), and risk of the valve to dislodge from the target site; subsequently, it resulted in valve migration during the systole and diastole.As such, available information suggests that procedural factors (valve malposition) may have contributed to the valve migration.Due to valve malposition (towards atrium), it is likely that the pvl skirt was not sealed against the implant site resulting in paravalvular leak.As such, available information suggests that procedural factors (valve malposition) may have contributed to the paravalvular leak.During the manufacturing process, all sapien 3 ultra valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.Per the technical summary, the cause of regurgitation varies depending upon multiple factors.Potential root causes for central regurgitation at time of implant includes valve malposition, slow recovery of blood flow, leaflet impingement due to calcification (for native landing zone), leaflet impingement due to guidewire, overinflation/ post-dilation, and under expansion.Typically, mild regurgitation is not unusual after initial valve replacement, and is usually tolerated by patients.Often moderate to high regurgitation requiring reoperation in the immediate post-operative period is due to patient and procedural related issues and is unrelated to the device.However, advances in valve design and bioprosthetic material have been made with the intention of reducing central leaks by providing more efficient hemodynamics and longer tissue durability.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, and flowco testing for each valve).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve preparation handling, and deployment.In this case, the central regurgitation was noted after the migration/ malposition of the valve.As such, available information suggests that procedural factors such as valve malposition 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 TRANSCATHETER HEART VALVE
• Type of Device: MITRAL VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16315671
• MDR Text Key: 309009427
• Report Number: 2015691-2023-10660
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)250814
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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
• Patient Sex: Female