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

Model Number 9750TFX26

Device Problem Material Integrity Problem (2978)

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

Event Date 01/23/2023

Event Type  malfunction  

Event Description

As reported, during deployment of a 23mm sapien 3 valve in aortic position by transfemoral approach, the valve embolized due to loss of capture during rapid pacing or due to a calcified sinotubular junction and landed low.The valve was moved/deployed to the descending aorta.A second valve was implanted to capture it.

Manufacturer Narrative

Investigation is ongoing.Device not returned.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.As no device was returned, no visual inspection, functional testing, or dimensional testing was performed.Imagery was provided by the site and reviewed.Patient had tortuous and calcified anatomy.One (1) strut bent outward at the inflow was noted.A lot history review was performed using the valve serial numbers from the related work order and revealed no other complaints relating to the relevant complaint codes.A complaint history review on confirmed device complaints (returned and no product returned) from (b)(6) 2022 to (b)(6) 2023 for the sapien 3 ultra thv (all models and sizes) was performed with the codes identified below.Prior closed complaints with any of the codes below were reviewed for similar events and root cause identification.Of the root causes identified, the following are potentially applicable to the complaint event: patient factors (calcification, tortuosity).All inspections are conducted on 100% of units unless otherwise specified.During incoming inspection of the components, the valve frames are 100% dimensionally inspected and 100% visually inspected by both manufacturing and quality for material loss, protrusions, distortions, poor finish, fracture/crack, and holes.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The edwards s3 and s3u with commander delivery system ifu and procedural training manual were reviewed.It notes ''if push force is too high or valve is initially stuck, zoom in and rotate the c-arm to ensure valve and sheath are not damaged.'' no ifu/training 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 frame damage was confirmed based on provided imagery.A review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.As reported, ''during procedure, there was no resistance felt when inserting the commander delivery system with crimped valve through the esheath, but after valve alignment done in the ascending aorta, it was noted a valve strut bent so the devices were retrieved as one unit with the esheath and the procedure was aborted.'' per imaging evaluation, the patient's anatomy had presence of calcification and tortuosity.Based on the complaint history review, the presence of calcification, tortuosity can create a challenging pathway during delivery system advancement, leading to interaction between crimped valve and patient's anatomy, so the further device maneuvering will lead to the bent strut as reported.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (device maneuvering) may have contributed to the complaint event.However, a definitive root cause was unable to be determined at this time.Since no device problem was identified affecting distributed product, no pra is required.Since no edwards defects were identified, no corrective or preventative actions are required.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.

Event Description

As reported, during the 26mm sapien 3 ultra case by transfemoral approach in aortic position, there was no resistance felt when inserting the commander delivery system with crimped valve through the esheath, but after valve alignment done in the ascending aorta, it was noted a valve strut bent so the devices were retrieved as one unit with the esheath and the procedure was aborted.The esheath was not damaged.No patient injury occurred, and patient was fine.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
• Type of Device: AORTIC 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: 16382791
• MDR Text Key: 309644661
• Report Number: 2015691-2023-10821
• Device Sequence Number: 1
• Product Code: NPT
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX26
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male