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

Model Number 9600LDS29A

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

As reported by the edwards field clinical specialist, during a transfemoral case in aortic position, during inflation of a 29mm commander delivery system, there was resistance in inflating the balloon to deploy the valve.The 29mm sapien 3 valve was 1mm higher than the distal marker band.The valve began to inflate more distally and eventually dog boned and anchored within the calcium.Upon deflation, the balloon did not deflate.It took multiple attempts to deflate the balloon, requiring a longer pacing run.The balloon deflated and there was no injury to the patient.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

The returned devices were visually inspected, and the following was observed: radial compression of flex shaft approximately 4 inches from flex tip.Kink on balloon shaft just proximal of warning marker, likely due to packaging.During pre-decontamination evaluation, the following functional testing was performed: able to successfully lock/unlock and perform full valve alignment (gross alignment and fine adjust) with no issues; able to successfully inflate/deflate with no issues.Locknut/collet force measurements met specification.Inflation/deflation time measurements met specification.Imagery was provided by the site and revealed the following: the inflation balloon was fully inflated and transcatheter heart valve was deployed.The patient's access vessels, aorta, and native annulus were calcified.The patient's access vessels were undersized.The complaints for inflation difficulty and partial/slow balloon deflation were unable to be confirmed as the complaint events could not be replicated on the returned device during evaluation.Visual, functional, or dimensional analysis did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/ training materials revealed no deficiencies.As reported, "the valve began to inflate more distally and eventually dog boned and anchored within the calcium.Upon deflation, the balloon did not deflate.It took multiple attempts to deflate the balloon, requiring a longer pacing run.The balloon deflated and there was no injury to the patient." as no abnormalities were observed during device preparation and neither the inflation nor deflation difficulty were able to be re-created during evaluation of the returned device, it is likely that calcification of the patient's native anatomy resulted in an inadvertent torquing of the device.Under these conditions, calcified anatomy can present difficult angles or constrained conditions resulting in higher resistance for the delivery system to overcome during tracking and subsequently affecting inflation and deflation.Per the training manual, "to prevent kinking of the delivery system, do not torque the handle while rotating the flex wheel" and "ensure the edwards logo is facing up on the delivery system." it is possible that the system was excessively manipulated/torqued during tracking, compromising the integrity of the components involved in the fluid path and contributing to the reported slow inflation and deflation of the balloon.However, a definitive root cause is unable to be determined.Available information suggests patient factors (calcification) and/or procedural factors (torquing the device) contributed to the inflation difficulty, and partial/slow balloon deflation.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 this adverse event is not required at this time.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16281069
• MDR Text Key: 308918801
• Report Number: 2015691-2023-10487
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)240807(10)64526657
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• Device Catalogue Number: 9600LDS29A
• Device Lot Number: 64526657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• 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