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

Model Number 9750CM

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure with a 29mm sapien 3 ultra resilia valve, the commander delivery system balloon was noted to take a bit longer to deflate.Upon inspection of the device, there was blood noted in the atrion.The system was removed without issue, and a pin hole noted at the level of the proximal shoulder of the balloon.The patient was stable throughout the procedure.Per report, the patient had a 580 annulus that had extensive stj calcifications.We prepped the balloon with 3 cc's out with the plan of adding them back with a more ventricular post dilation.Crossed the native valve without issue.Started with the middle marker at the base of the cusps and aligned the top of the valve below the stj.Flex catheter was removed.Began pacing.Inflation was slow and steady until all volume was out of the inflation device.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.The ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The 3mensio report video and imagery was provided by the site, and the following was observed: calcification was present in the patient anatomy.Tortuosity was present in patient.There was a pin hole on the working length of the inflation balloon.In this case, the reported event of balloon leak was confirmed through the provided imagery, and the reported event of deflation difficulty was unable to be confirmed due to the device not being returned.As reported, 'the patient had a 580 annulus that had extensive stj calcifications.The commander delivery system balloon was noted to take a bit longer to deflate.Upon inspection of the device, there was blood noted in the atrion.The system was removed without issue, and a pin hole noted at the level of the proximal shoulder of the balloon'.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• 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 (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: 18771904
• MDR Text Key: 336902896
• Report Number: 2015691-2024-01295
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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