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

Model Number 9750CM26A

Device Problem Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure with a 26mm sapien 3 ultra resilia, the valve was noted to be a millimeter or two past the distal maker on the balloon during valve alignment.However, the operator decided to deploy.During deployment, the proximal end of the balloon flared the back portion of the valve during inflation resulting in the valve migrating to the distal portion of the balloon (valve had a cone shape).The team was able to snare the valve to hold it in place, and the valve was then partially deployed with a 10mm peripheral balloon.The commander delivery system was removed from the patient, and a new commander delivery system was nominally prepped with 23cc and used to fully deploy the valve.The patient was stable exiting the room.

Manufacturer Narrative

The returned device was visually inspected, and the following was observed: the balloon was returned fully unpleated.Functional testing of the device was performed, and the following was observed: locking/unlocking and fine adjustment was performed successfully with no issues.Imagery was provided by the site and revealed the following: thv not centered over valve alignment markers during thv positioning prior to inflation, and incomplete partial inflation of thv.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 complaint for valve not aligned between markers and deployed, was confirmed by review of provided imagery.As reported, 'the valve was noted to be a millimeter or two past he distal marker on the balloon during valve alignment.However, the operator decided to deploy.During deployment, the proximal end of the balloon flared the back portion of the valve during inflation resulting in the migrating to the distal portion of the balloon'.The instructions for use and training manuals instruct the user to 'ensure that the valve is correctly positioned between the valve alignment markers.' if the valve is not between the valve alignment markers as observed, it will not be oriented fully over the inflation balloon working length, leading to incomplete or asymmetrical deployment, as observed.As such, available information suggests that procedural factors (misaligned valve on inflation balloon, valve not aligned between markers and deployed) 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: 16423269
• MDR Text Key: 310039592
• Report Number: 2015691-2023-10996
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)240918(10)64609683
• 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: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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: 64609683
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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