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

Model Number 9610TF29

Device Problems Failure to Align (2522); Unintended Movement (3026)

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

Event Date 06/14/2023

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.The device was returned for evaluation.Investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate in germany, regarding an implant case of a 29mm sapien 3 valve in aortic position by transfemoral approach.During procedure, the fine alignment was harder than normal but the valve was aligned between balloon markers.When deploying the valve, only the ventricular part of the valve opened and the proximal valve part did not dilate.There was an asymmetrical deployment of the valve.The valve "migrated" towards the aorta.The valve was pushed into the ventricle.Patient was transferred to surgical removal and replacement of the valve.The patient was in good condition.

Manufacturer Narrative

The device was returned for evaluation.The returned device was visually inspected during pre-decontamination evaluation and the following was observed distal balloon catheter received cut at crimp balloon, kink noted in proximal balloon catheter between default and warning markers due to packaging, valve was partially expanded (cone shape) at inflow side (distal) over the cut inflation balloon.The returned device was visually inspected during post-decontamination evaluation and the following was observed ring-shaped separated component of unknown origin was noticed over the proximal balloon shaft between default and warning markers (after gross alignment test performed), handle was disassembling by engineers.Stop sleeve to balloon shaft bonds broken at both sides.Stretching of the balloon shaft braiding was noticed.Also, abrasions observed at proximal stop sleeve/balloon shaft bond.The returned delivery system was tested for valve alignment function.The device was able to perform full gross alignment and fine adjustment without difficulty.Additionally, functional testing was performed post-decontamination and the following was observed the returned delivery system was tested for valve alignment function.The device was able to perform full fine adjustment without difficulty.However, resistance was noticed when performing valve gross alignment with the kinked portion of the balloon catheter.After resistance was overcome, a ring-shaped separated component of unknown origin was observed.Imagery was provided and the following was observed valve was partially expanded at inflow side (distal) over the cut inflation balloon, and partially aligned over inflation balloon.The reported event for fine adjustments was unable to be confirmed by visual inspection of the returned device.No manufacturing non-conformance was identified during the evaluation.An existing technical summary written by edwards lifsciences has been documented for root cause analysis on tension build up in the system due to valve alignment difficulty.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event.If valve alignment was performed in a tortuous vasculature (non-straight section), this could have caused the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and dive into the flex tip.If the thv was unseated from the flex tip during alignment, it could have resulted in higher-than-normal alignment forces creating high tension in the system, which could have consequentially lead to the reported valve alignment difficulties.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.Review of available information suggests that procedural factors (built up tension) contributed to the reported event.The reported event of valve moves on balloon was confirmed by visual inspection of the returned devices and the provided imagery.A review of dhr, lot, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of ifu/training materials also revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation; therefore, it is unlikely that a manufacturing nonconformance contributed to the reported events.As reported, when deploying the valve, only the ventricular part of the valve opened and the proximal valve part did not dilate.There was an asymmetrical deployment of the valve.The valve migrated towards the aorta.There is insufficient information to determine a definitive root cause at this time.However, it is possible that procedural factors may have contributed to the complaint events.As reported, valve alignment difficulty was experienced, which may have led to incomplete alignment of the thv over the valve alignment markers.The procedural training manual states to check that the thv is exactly between the valve alignment markers prior to deployment, as deploying with the thv off the markers may result in valve movement on balloon and asymmetrical inflation as reported.Although it was reported that the valve was aligned between the markers, due to lack of procedural imagery this was unable to be confirmed.As such, a definite root cause of the valve movement on balloon is unable to be determined at this time.The reported event of component separation was confirmed by visual inspection of the returned devices and the provided imagery.A review of dhr, lot, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of ifu/training materials also revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation; therefore, it is unlikely that a manufacturing nonconformance contributed to the reported events.During the device evaluation, resistance was experienced when performing gross alignment functional testing.There was difficulty moving the balloon shaft from default marker to warning marker, most likely due to a kink in the balloon shaft caused by packaging of the returned complaint device.Once the resistance was overcome, a ring-shaped component separation was observed over the proximal balloon shaft.Based on the chemistry evaluation performed, it was determined that the ring-shaped component separation most likely originated from the strain relief.It is possible that the excessive manipulation required to pass the kinked section of the balloon shaft through the strain relief during gross alignment functional testing damaged the inner diameter of the strain relief, dislodging a ring-shaped portion of the strain relief material and resulting in the observed component separation.Additionally, while abrasions were identified at the site of the stop sleeve/balloon shaft proximal bond, this may be attributed to breakage of the bond due to excessive tension during the reported valve alignment difficulty.Combined with the results of the chemistry evaluation, it was determined that this is not the source of the component separation.Investigation has determined that the source of the component separation was likely the strain relief, and that creation of the component separation occurred during excessive manipulation of the device during post-decontamination evaluation.As such, there was no risk of patient exposure to the separated component in this case.Review of available information suggests that procedural factors (excessive manipulation during device evaluation, kinked balloon shaft) contributed to the reported event.

• 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: 17288743
• MDR Text Key: 318822939
• Report Number: 2015691-2023-14475
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Device Lot Number: 64967634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2023
• 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