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

Model Number 9750TFX26

Device Problem Material Twisted/Bent (2981)

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

Event Date 11/16/2022

Event Type  malfunction  

Event Description

As reported by our edwards affiliate in canada, during a transfemoral tavr procedure, no issues during the advancement of a 26mm sapien 3 ultra valve and commander delivery system through the esheath were reported.When the valve exited the sheath, it became caught on calcium in the descending aorta.A valve strut became 'unaligned with the rest of the valve', bent.The decision was made to move the valve to the aortic annual and attempt deployment.However, the valve was not able to cross the native leaflets.Since the system could not be removed with the valve on the balloon, it was decided to deploy the valve in the descending aorta.Once the valve was deployed, the delivery system and sheath were removed.A non-edwards valve was then successfully deployed, and the procedure was completed.The patient was stable throughout the procedure.No vascular complications were reported.It was perceived that patient calcification contributed to the event.

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.This is one of two manufacturer reports being submitted for this case.

Manufacturer Narrative

Corrected information: section h6 additional information: section h10 the sapien 3 ultra valve was not returned to edwards lifesciences for evaluation.Without the device, visual inspection, functional testing and dimensional analysis could not be performed.Review of the provided case imagery revealed one strut was bent outward on the valve inflow side.Device history review (dhr) review was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review revealed no other similar complaints.In this case, the complaint for 'frame damage' was confirmed based on imagery provided.No potential manufacturing non-conformance were identified.Review of the dhr and lot history review did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.As reported, 'no issues were faced passing valve through the esheath but there was a resistance once the valve exited the esheath.Valve was caught on some calcium in the descending aorta and a strut became unaligned with the rest of the valve'.Additional, noted that patient had calcification in the descending aorta.Per training manual, 'push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification'.The calcification could create a challenging pathway during delivery system navigation through the patient anatomy and lead to resistance with high push force.So, if excessive force was applied to overcome the resistance during the delivery advancement, the valve strut can get caught within the calcify access vessel resulting in reported bent strut.Available information suggests in addition to procedural factors (excessive device manipulation, high push force), patient factors (vessel calcification) may have contributed to the damaged valve frame.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 this adverse event is not required at this time.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 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.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: (b)(4).

• Brand Name: EDWARDS SAPIEN 3 ULTRA
• 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: 15882520
• MDR Text Key: 306506631
• Report Number: 2015691-2022-09543
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9750TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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 Age: 89 YR
• Patient Sex: Male