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

Model Number 9750TFX26A

Device Problem Material Deformation (2976)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

As reported by the field clinical specialist, during a right transfemoral tavr procedure, the 26 mm sapien 3 ultra valve became stuck in the 14f esheath upon insertion of valve and 26 mm commander delivery system.Multiple attempts were made to advance the valve through the esheath.The physician requested a new valve and 16f esheath, and the procedure was completed successfully with no patient complications.Upon the removal of 14f esheath and delivery system, it was noted that valve was stuck on the side wall of the esheath.However, they were unable to determine if there was frame damage because valve remained inside the sheath.The engineering evaluation of the returned devices revealed a sheath shaft puncture approximately 1.5 inches from the strain relief caused by a valve strut.It was found that the valve struts were bent.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

A supplemental is being submitted for the completed engineering evaluation.Sections b.2, b.4, g.3, g.6, h.2, and h.3 have been updated.Corrections have been made to h.6: type of investigation, investigation finding, and investigation conclusion, and impact code.An additional code was added to h.6: component code.The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.Per the technical summary, the instructions for use (ifu), current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The device was returned for evaluation.The returned device was visually examined for any abnormalities and the following was observed: the crimped valve was exposed through the sheath, one strut was bent at the inflow side, multiple struts were exposed through the skirt which was normal after excessive manipulation during the insertion, the frame was distorted, and the leaflets were wrinkled and dehydrated due to the storage conditions (prolonged crimping) during the return handling process.Due to the nature of the complaint, no applicable dimensional or functional testing was performed.The complaint for frame damage was confirmed based on visual examination of the device returned.As reported, there was difficulty advancing the delivery system through the sheath, resulting in difficulty or the inability to introduce the delivery system and advance through the sheath, prolonging the procedure.Available information suggests procedural factors (excessive manipulation/high push force) likely contributed to the event as the strut was bent outward at the inflow side.Excessive device manipulation or high push force can lead to the valve struts interacting with the sheath shaft and result in the strut damage at the valve inflow side.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18499509
• MDR Text Key: 333113295
• Report Number: 2015691-2024-00311
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)260807
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• 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 Sex: Male