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

Model Number 9600LDS23J

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.Other text: na.

Event Description

In this case, during transfemoral transcatheter aortic valve replacement (tavr) procedure, upon advancing of the commander delivery system in the aortic arch, a 23mm sapien 3 valve was stuck on the calcification and a strut was deformed.It was difficult to remove the delivery system from the esheath.However, the delivery system was stuck on another calcification and could not be moved.Therefore, the valve was deployed in the aortic arch.The tavr procedure was cancelled.

Manufacturer Narrative

Investigation is still ongoing.

Event Description

In this case, during transfemoral transcatheter aortic valve replacement (tavr) procedure, upon advancing of the commander delivery system in the aortic arch, a 23mm sapien 3 valve was stuck on the calcification and a strut was deformed.It was difficult to remove the delivery system from the esheath.However, the delivery system was stuck on another calcification and could not be moved.Therefore, the valve was deployed in the aortic arch.The tavr procedure was cancelled.

Manufacturer Narrative

The following report fields have been updated due to additional information received: g3, h6.The edwards commander delivery system was not returned for evaluation, therefore visual, functional, and dimensional testing was not performed.A review of complaint activities and attachments revealed no additional information relevant to the complaints event.A device history record (dhr) review of the work orders did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed based on a technical summary that applies to this complaint; an engineering evaluation is not required.A review of instructions for use (ifu)/training material for commander delivery system (ifu), preparation and procedural training manuals were reviewed.Per cautions, visually inspect all components for damage.Ensure the delivery system is fully unflexed and the valve alignment wheel is adjacent to the handle.Caution: to prevent possible damage to the balloon shaft, ensure that the proximal end of the balloon shaft is not subjected to bending.Ensure there is no residual fluid left in the balloon to avoid potential difficulty with valve alignment during the procedure.Unflex the delivery system while retracting the device, if needed.Verify that the flex catheter tip is locked over the triple marker and remove the delivery system from the expandable sheath.Retract the thv and delivery system into the sheath ensuring the thv is completely inside the sheath and just past the sheath tip.Withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.No ifu/training deficiencies were identified.The complaints for "navigate and position catheter to target location - unable to track system through anatomy" and "withdraw catheter and valve through vasculature / sheath - difficulty or inability to withdraw system with valve through sheath," were unable to be confirmed due to unavailability of returned device and /or applicable imagery.Due to unavailability of the device, engineering was unable 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 complaint history review is not required.A review of the ifu and training manuals revealed no deficiencies.As reported, "upon advancing of a commander delivery system in the aortic arch, a 23 mm sapien 3 valve was stuck on the calcification, and a strut was deformed." obstructive calcification may have prevented the advancement of delivery system.The valve may have interacted with calcium nodes in the advancement pathway and the system was unable to be progress further."the delivery system was tried to be pulled into the esheath.However, the delivery system was stuck another calcification and could not be moved." the interaction with calcification may have contributed to withdrawal difficulty as well as non-coaxial withdrawal of the delivery system into the sheath, making the device more susceptible to catching on the sheath tip.Additionally, it is possible the delivery system profile was altered due to the reported bent valve strut, making the device more susceptible to catching on the tip of the sheath.The complaint for "withdraw catheter and valve through vasculature / sheath - difficulty or inability to withdraw system with valve through sheath" was confirmed.The complaint for "navigate and position catheter to target location - difficult to track system through anatomy" was unable to be confirmed.However, no manufacturing nonconformances were identified during evaluation.Available information suggests patient (calcification) and procedural factors (withdrawal of bent valve struts/non-coaxial withdrawal) contributed to the reported event.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is required at this time.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.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.In this case, patient factors (calcification) and/or procedural factors may have contributed to the valve was implanted in a non-target location, the aortic arch.Valve deployment in unintended location is listed in the instructions for use (ifu) as a potential risk associated with the tavr procedure, the bioprosthesis, and the use of its associated devices and accessories.There may be cases in which the valve is not able to be deployed at the intended location for various reasons.This may require deploying the valve at a non-target location, typically in the descending aorta.

• 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: 12849748
• MDR Text Key: 285414846
• Report Number: 2015691-2021-06417
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Model Number: 9600LDS23J
• Device Lot Number: 63742484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female