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

Model Number 9610TF29

Device Problems Fluid/Blood Leak (1250); Material Perforation (2205); Failure to Align (2522)

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

Event Date 10/14/2022

Event Type  Injury  

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 france.During a transaxillary tavr procedure, difficulties were encountered during the alignment of a 29mm sapien 3 valve on the commander delivery system balloon.The valve did not pass the warning marker.After manipulation of the devices, the valve was properly aligned.During valve deployment, the valve would not inflate.It was determined that the balloon had been perforated.The delivery system and sheath were removed.A balloon catheter was used to capture the valve was deploy it in the ascending aorta.A new valve delivery system and sheath were prepared.The second valve was successfully implanted.At the time of the report, the patient was in stable condition.Both valves remain implanted in the patient.

Manufacturer Narrative

The commander delivery system was returned to edwards lifesciences for evaluation.During functional testing, the balloon shaft was able to be pulled from the default marker to the warning marker, locked and full fine adjust was utilized without issue.The delivery system could be locked and unlocked without issue.Due to the nature of the complaint (pinhole on proximal balloon shoulder and not on working length of balloon), no applicable dimensional testing was able to be performed.Pre-decontamination evaluation of the returned device revealed the balloon was punctured on the proximal side.Post decontamination evaluation revealed the inflation balloon was returned unpleated.Flex tip gouges were observed, and a pinhole leak was observed on the proximal shoulder when inflated.Review of the provided case imagery showed the initial sapien 3 valve and delivery system.The initial valve was fully expanded.The imagery also showed the initial valve was deployed in a non-target location.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 for 'valve alignment difficulty or inability - fine adjust' and 'valve alignment difficulty or inability - gross alignment' were not able to be confirmed as no applicable procedural imaging was provided for evaluation, as well as returned testing showed device functioned as designed.However, the complaint for 'balloon leak' was confirmed based on evaluation of the returned complaint device.No manufacturing non-conformances were identified during engineering evaluation.A review of dhr, lot history, manufacturing mitigations and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu and training manuals revealed no deficiencies.As reported, 'during procedure, there were difficulties to align the thv on the commander's balloon.The valve alignment was attempted in the ascending aorta which was quite straight.Valve alignment was quite difficult, but the physician followed edwards recommendations.It was found difficulties during both fine and gross alignment, but the physician did not past the warning marker and finally alignment was done properly'.It was also reported that, 'during the deployment, it was noted that the balloon was perforated and did not inflate the valve, which complicated the procedure' and 'probably during valve alignment, the thv perforated the commander balloon'.Excessive force may have been applied during the attempts at valve alignment to overcome the reported resistance.Additionally, excessive force may have caused the struts of the crimped thv to impinge on the inflation balloon during valve alignment, possible damaging the balloon and resulting in the observed inflation balloon leak observed during device evaluation.It was additionally reported that the subclavian artery was very tortuous.The tortuosity seen in the subclavian/auxiliary can create suboptimal areas for valve alignment and cause bending of the distal end.It is possible that tension may have been introduced onto the system leading to the reported valve alignment difficulties.The exact cause of tension is unknown; however, possible sources are a tortuous anatomy.Attempts to align valve over inflation balloon in these conditions can lead to the valve catching onto balloon material and contributing to the valve alignment difficulties reported.As such, it is possible that valve alignment was performed in a non-straight section of vasculature which can cause the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and 'dive' into the flex tip, as suggested by the flex tip gouges.If the thv is unseated from the flex tip during alignment, it can result in higher-than-normal alignment forces creating high tension in the system which can consequentially lead to the reported valve alignment difficulties.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.The study revealed that performing valve alignment in a curvature appears to increase the possibility of 'diving' (thv become unseated from the flex tip), which in turn increases valve alignment force.Higher alignment force appeared to have a higher likelihood of occurrence at tighter radii.Although a definite root cause was not able to be determined, available information suggests in addition to procedural factors (valve alignment in non-straight section, high alignment factors, excessive manipulation), patient factors (vessel tortuosity) may have caused or contributed to the reported valve alignment difficulties and delivery system balloon puncture.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 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: 15711897
• MDR Text Key: 302827476
• Report Number: 2015691-2022-08950
• 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: 01/16/2023

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 Expiration Date: 11/18/2023
• Device Model Number: 9610TF29
• Device Catalogue Number: NA`
• Device Lot Number: 64106366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 01/14/2023
• Supplement Dates FDA Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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: 75 YR
• Patient Sex: Male