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

Model Number 9750TFX23A

Device Problems Fluid/Blood Leak (1250); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.Device remained implanted.

Event Description

Edwards received notification from a field clinical specialist that during a transseptal mitral valve in ring, two 23 mm s3u valves were implanted.As reported, this was a vir procedure with stenotic edwards annuloplasty ring.The operator requested to use 16fr sheath to allow for smooth removal of valve/ds if unable to cross septum.The first 23 mm s3u valve was implanted successfully with a 90/10 position.Upon removal of ds, leaflet disruption was noted by tee showing moderate mr.The operator made the decision to implant a second 23 mm s3u valve.Tee assessment showed none/trace mr post implant of second valve.

Manufacturer Narrative

The device was not returned for evaluation as it was remained implanted/discarded.Therefore, a no product return engineering evaluation was performed.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 valve central regurgitation and leaflet motion restricted were unable to be confirmed as no imagery/ medical record was provided for evaluation.A review of dhr did not indicate any manufacturing nonconformance that could have contributed to the reported event.A review of the ifu and training manuals revealed no deficiencies.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 an edwards' 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.As reported, ''the first 23mm s3u valve was implanted successfully with a 90/10 position.Upon removal of ds, leaflet disruption was noted by tee showing moderate central mitral regurgitation (mr)''.Additionally, the delivery system balloon fluid was adjusted with additional 3cc.In this case, the additional volume may overexpand the deployed valve resulting in the leaflet motion restricted and improper leaflet coaptation or central regurgitation.As such, available information suggests that procedural factors (valve over expanded) may have contributed to the complaint event.The technical summary is applicable to this event because it reports of central regurgitation and leaflet motion restricted noted at time of the implant and likely related to procedural factors.Since no labeling or ifu/training inadequacies were identified; no corrective/preventive action nor product risk assessment (pra) is required.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.

• 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: 15316163
• MDR Text Key: 298870989
• Report Number: 2015691-2022-07588
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(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: 10/18/2022

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 Model Number: 9750TFX23A
• 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
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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: Male