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

Model Number 9750CM26A

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a trans-carotid tavr procedure with a 26mm sapien 3 ultra valve, the operator pulled the commander delivery system back to the warning marker and attempted to lock.However, the balloon catheter shaft shifted back into the handle, not exposing the warning marker, and not allowing the fine adjustment wheel to further align the valve between the radio-opaque markers.Several attempts were made to troubleshoot, however, it was unsuccessful.The team decided to withdrawal the devices, but they were unable to get the valve back into the esheath.It was decided to deployed the valve in the ascending aorta using multiple balloon inflations.Post deployment, the commander delivery system was removed with no issues.It was then decided to try trans-apical approach with a new valve.After the team pulled the wire and closed the carotid, final angio picture showed the valve in descending had turned 90 degrees, and the patient needed an open procedure.The embolized valve was surgically removed and a surgical valve was implanted.

Manufacturer Narrative

The device was returned to edwards lifesciences for evaluation.Visual inspection was done on the returned device, and the following was observed: tab ring displaced 90 degrees from the correct orientation, and a crack was observed on tab ring.Functional testing was performed on the returned device, the tab ring was returned to the correct position, and engineers were able to pull the balloon shaft to the warning marker, and lock/utilize full fine adjustment with no abnormalities observed.Additionally, the locknut/collet force measurements were taken of the returned device, and measurements met specification.Imagery provided from the site was evaluated, and the following was observed: the thv was observed expanded within the patient's anatomy.A device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 for valve alignment difficulty, system component damaged, and difficulty to withdraw system with valve through esheath were confirmed based on evaluation of the returned complaint device and provided imagery.As reported, 'the operator pulled the commander delivery system back to the warning marker and attempted to lock.However, the balloon catheter shaft shifted back into the handle, not exposing the warning marker, and not allowing the fine adjustment wheel to further align the valve between the radio-opaque markers'.Per preliminary findings, the tab ring was returned in the incorrect orientation with a crack observed.Initial functional testing of the device showed the balloon shaft of the delivery system was movable even when locked.However, after returning the tab ring in the correct orientation, the device then showed no issues with the balloon lock or fine adjust mechanism.It is likely the observed crack on the tab ring was a result of excessive manipulation and over torquing the wing nut of the handle when locking/unlocking the device, displacing the tab ring from the slider.Available information suggests that procedural factors (excessive manipulation, displaced tab ring) may have contributed to the complaint event.As reported, 'it was decided to withdrawal the devices, but were unable to get the valve back into the esheath.The team decided to deployed the valve in the ascending aorta using multiple balloon inflations.Post deployment, the commander delivery system was removed with no issues'.The withdraw difficulty with valve through sheath could be potentially from multiple factors (i.E.Tortuous anatomy, non-coaxial retrieval through sheath, improper withdrawal technique, altered profile of crimped valve).Under these factors, the thv may be more susceptible of catching onto the sheath tip and result in the reported withdrawal difficulties.However, without applicable patient/procedural imagery, a definitive root cause is unable to be determined.Available information suggests that procedural factors (non-coaxial withdrawal, withdrawal of altered profile) 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 corrective or preventative actions are required.

• 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: 16450627
• MDR Text Key: 310326777
• Report Number: 2015691-2023-11133
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)241106(10)64705092
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 64705092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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