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

Model Number 9600LDS29A

Device Problem Difficult to Remove (1528)

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

Event Date 01/24/2023

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 29mm sapien 3 valve, during valve alignment while loading the balloon into the esheath, the mechanism wasn't working.The team pulled the line back and proceeded to roll the wheel to move the balloon, and the balloon would not move.The team tried unlocking, moving the wheel, and relocking, but the balloon would not come back.The decision was made to get a new delivery system, so the delivery system, esheath, and valve were removed as a unit.However, while withdrawing the systems, the valve would not back out of the artery.A cutdown was performed to get the device out, and a new 16fr esheath was inserted.The new valve was then deployed.

Manufacturer Narrative

Visual inspection was performed on the returned device, and following were observed: the strain relief was bunched on the delivery system.Functional testing was performed on the returned device.Engineering was able to perform full valve alignment by pulling to full gross alignment, locking the device, and utilizing full fine adjustment without resistance.After the decontamination process, engineering was able to perform full valve alignment by pulling full gross alignment, locking the device, and utilizing full fine adjustment without resistance.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 and difficulty to withdraw system through vasculature were unable to be confirmed as applicable imagery was not provided.As reported, 'during valve alignment while loading the balloon into the esheath + the mechanism wasn't working.The team pulled the line back and proceeded to roll the wheel to move the balloon and the balloon would not move.While withdrawing the systems the valve would not back out of the artery'.As no patient or procedural imagery was provided, a definite root cause is unable to be determined, however patient factors such as tortuosity can create challenging pathway for the delivery system gross alignment.In addition, tortuosity can cause non coaxial withdrawal with the delivery system and valve catching on the sheath distal tip leading to the difficulties noted.However, without applicable 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, non-coaxial withdrawal) 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: 16393937
• MDR Text Key: 309736740
• Report Number: 2015691-2023-10901
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)241019(10)64631806
• 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: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• Device Catalogue Number: 9600LDS29A
• Device Lot Number: 64631806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• 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?: Yes
• Date Device Manufactured: 10/20/2022
• 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