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

Model Number 9610TF29

Device Problem Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2022

Event Type  Injury  

Event Description

As reported, it was a case of a 29mm sapien 3 valve, by transfemoral approach.During procedure, valve alignment was not fully possible, due to very high forces.The valve was attempted to be implanted; however, the valve only expanded in the ventricular direction and embolized into the ventricle.The patient had to underwent surgery.Patient is in stable condition post procedure.

Manufacturer Narrative

The implant position and characteristics and lot number are unknown.The investigation is ongoing.The device has not been received.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-10342.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.3 device evaluated by manufacturer, h.6 impact code and investigation conclusions and investigation findings.Added new information to d.9 returned manufacturer, h.6 type of investigation.The device was returned to edwards lifesciences for evaluation and the following was observed.Asymmetrically expanded sapien 3 valve remained on inflation balloon and distal end of delivery system cut at the crimp balloon.Gouges observed on the flex tip.Compression observed along the flex shaft.X-rays of handle taken revealed no abnormalities observed.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was confirmed.No manufacturing non-conformances were identified during engineering evaluation.A review of the dhr, complaint history, 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.As reported, ''during procedure, fine alignment was not fully possible, due to very high forces.It was tried to de-lock the system several times to minimize tension, but it was not possible to fully align the valve''.Per fcs follow-up, tortuosity in the aorta/iliacs was mild.As such, 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 evidenced by the observed 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 can be noted from flex tip gouges on the returned device, which in turn increases valve alignment force.Higher alignment force appeared to have a higher likelihood of occurrence at tighter radii.However, without applicable patient/procedural imagery, a definitive root cause is unable to be determined.Available information suggests that patient (tortuosity) and/or procedural factors (valve alignment in non-straight section) may have contributed to the complaint event.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 ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: 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: 16043054
• MDR Text Key: 306085152
• Report Number: 2015691-2022-10327
• 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,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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