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

Model Number 9610TF29

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/04/2023

Event Type  Injury  

Event Description

Edwards received notification from our affiliate in germany.As reported, this was a case of an implant of a 29mm sapien 3 valve in aortic position by transfemoral approach.During the procedure, it was not possible to perform the gross valve alignment properly, the sapien 3 valve could not be pulled correctly onto the balloon because it was needed to apply a high force.Despite of the fact that the valve was not correctly aligned with the balloon, it was decided to deploy the valve as the patient's extreme cardiac unstable status (patient needed reanimation).When deploying the valve, it jumped upwards and the outflow was only opened.Therefore, the valve could not be retrieved at this point and it was decided to deploy it in the descending aorta.No difficulties were found during withdraw the delivery system from the patient after valve deployment.Due to the unstable overall situation and poor condition of the patient, a second sapien 3 kit was not used, the patient had to be opened and received a bioprosthesis.

Manufacturer Narrative

The investigation is in progress, a supplemental report will be submitted.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.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.The complaints gross and fine adjustment valve alignment difficulty was confirmed based on evaluation of provided imagery.However, a manufacturing non-conformance was unable to be determined.Additionally, a review of the 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.As reported, ''during procedure, it was not possible to perform the gross valve alignment properly, the sapien 3 valve could not be pulled correctly onto the balloon because it was needed to apply a high force.'' while no imagery of the patient anatomy was provided, it is possible that valve alignment was conducted in a non-straight section.If valve alignment was performed in a tortuous (non-straight section) vasculature, this can cause 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 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 observed 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.Without further information or applicable imagery, a definitive root cause is unable to be determined at this time.However patient factors (tortuosity) and/or procedural factors (high alignment forces, valve alignment in a non-straight section) may have contributed to the reported event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation ( capa/scar/pra) is required.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.

• 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: 16258676
• MDR Text Key: 308308107
• Report Number: 2015691-2023-10421
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: 64284503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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