MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF26U

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problem Vascular Dissection (3160)

Event Date 10/11/2021

Event Type  Injury  

Event Description

As reported by our affiliate in finland, a 26mm sapien 3 ultra valve was implanted in the aortic position using the transfemoral approach.During the valve alignment process, the valve could not be positioned centrally and became 'stuck on the balloon'.An attempt was made to retrieve the valve back into the sheath, but during that process, the valve became stuck in the iliac artery.Vascular surgery was required to remove the valve.No further information regarding the patient status is available at this time.

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.

Manufacturer Narrative

Additional information received indicated the patient expired from complications following the vascular surgery needed to remove the devices from the iliac artery.The exact cause of death cause and timing of the patient death was not provided.

Manufacturer Narrative

The commander delivery system was not returned to edwards for evaluation.Without the device, visual inspection, functional testing and dimensional analysis could not be performed.No relevant case imagery was provided for review.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 complaints were not able to be confirmed as neither the complaint device nor applicable imagery were provided for evaluation.Due to the unavailability of the complaint device, engineering was not able to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined.A review of dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.The complaint description states, 'during procedure, during the valve alignment valve could not be centralized, it got stuck on the balloon.' as procedural imagery and patient information was not provided, there is sufficient information to determine a root cause.However, it is possible tension was present in the system during valve alignment, which may result in higher forces necessary to align the valve, contributing the reported complaint event.Tension in the system may be induced by the following: - if the balloon profile is altered, it may be difficult to advance the thv over balloon.The balloon profile may be affected by device preparation steps, such as inflating the balloon past the recommended 20-30% as instructed in ifu materials or leaving residual fluid in the balloon after de-airing.- tortuosity was noted to be present in the patient's vasculature.If tortuosity is present, it may be difficult to pull the balloon shaft through the flex shaft along bends in the anatomy.Furthermore, if the thv alignment is performed at an angle (non-straight section of aorta), this can cause the thv to unseat from the flex tip (non-coaxial placement of valve in relation to the flex tip) during alignment and 'dive' into the lumen of the flex tip.If the thv is unseated during alignment, it can result in additional valve alignment forces.Additionally, the complaint description reports, 'it was tried to retrieve the valve to the sheath, during that phase, the valve got stuck on the iliac.' as procedural imagery and patient information was not provided, there is sufficient information to determine a root cause.However, it is possible that patient factors contributed to withdrawal difficulties.The presence of tortuosity can result in the creation of sub-optimal angles during delivery system withdrawal that may lead to non-coaxial alignment.The presence of calcification within the access vessel can also create a constrained condition and further contribute to a non-coaxial withdrawal.Such non-coaxiality can contribute to withdrawal difficulties as the valve likely caught on the sheath tip, resulting in observed withdrawal difficulties.A definite root cause was not able to be determined.Procedural factors (device withdrawal difficulties), in addition to patient factors not provided (vascular characteristics) may have contributed to the reported vascular injury that occurred during the cutdown to remove the devices.A complaint history for this type of event is 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.No corrective or preventive actions are required.

• Brand Name: EDWARDS COMMANDER DELIVERY 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: 12734043
• MDR Text Key: 284357313
• Report Number: 2015691-2021-06118
• 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,Followup
• Report Date: 12/13/2021

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 Expiration Date: 04/28/2023
• Device Model Number: 9610TF26U
• Device Catalogue Number: N/A
• Device Lot Number: 63766828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 12/10/2021; 12/13/2021
• Supplement Dates FDA Received: 12/10/2021; 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death