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

Model Number 9750TFX26

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

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

Event Date 11/10/2022

Event Type  malfunction  

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.

Event Description

As reported by our edwards affiliate in canada, a 26mm sapien 3 ultra valve was deployed in the aortic position via the transfemoral approach.'high resistance' was encountered during the advancement of the valve and commander delivery system through the sheath.After the valve exited the sheath, fluorography indicted a strut on the inflow side of the valve was bent over.The valve and delivery system were pulled back into the sheath and removed without issue.A new valve, delivery system, and sheath were prepared and successfully used for the procedure.No vascular complications were reported.The patient was transferred to recovery in stable condition.The valve remains implanted in the patient.It was speculated that calcium in the iliofemoral artery may have contributed to the event.

Manufacturer Narrative

The sapien 3 ultra valve and commander delivery system were not returned to edwards lifesciences for evaluation.The sapien 3 ultra valve was not returned to edwards lifesciences for evaluation as it remains implanted in the patient.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 forward greater than 90 degrees at the inflow side.Two (2) struts were also bent outward greater than 90 degrees at the inflow side.The valve was also expanded post procedure and the 2 struts remained bent.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 provided imagery.A review of the dhr and lot 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, 'while advancing the commander delivery system with crimped valve through the esheath, it was experienced high resistance force.On fluoro, it could be observed that a strut on inflow portion of the valve was bent over' and per the complaint description, 'the perceived root cause of the reported event was potentially calcium in patient's iliofemoral artery'.Per training manual, 'push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification', 'if push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system', and 'do not over-manipulate the sheath at any time'.Additionally, per imaging evaluation, the patient's access vessel had presence of stent/calcification and tortuosity.The presence of calcification can create challenging pathway during delivery system advancement, leading to high resistance.So, if excessive force is applied to overcome the high resistance during the delivery system advancement, it can lead to the valve struts interacting the sheath shaft and resulted in the valve bent strut at the inflow.Available information suggests in addition to procedural factors (excessive device manipulation, high push force), patient factors (vessel calcification) may have contributed to the reported event.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.

• Brand Name: EDWARDS SAPIEN 3 ULTRA VALVE
• 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: 15835733
• MDR Text Key: 306506024
• Report Number: 2015691-2022-09389
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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 Sex: Female