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

Model Number 9610TF23

Device Problem Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure with a 23mm sapien 3 valve, the valve was not correctly aligned on the balloon, and it was inflated asymmetrically, leading to a valve low position of 30/70 (aortic/ventricular).There was no additional actions taken at the time of the procedure.

Manufacturer Narrative

Correction to h6 based on additional information.The device was not returned to edwards lifesciences 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.In this case, the reported event of the valve not being between the alignment markers and deployed was unable to be confirmed due to the device or appropriate imagery not being returned/provided.Per the event description, the valve was not between the alignment markers prior to valve deployment.If the crimped valve was not within the internal shoulders prior to deployment, the deployed valve could be inflated asymmetrically, and thus, pushed towards aorta and/or left ventricle during the deployment, leading to the reported low valve positioning (30/70).Per the training manual, 'slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap'.'check to ensure: thv is exactly between the valve alignment markers'.As such, available information suggests that use error (not following ifu/training manual) 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: 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: 18799694
• MDR Text Key: 336863804
• Report Number: 2015691-2024-01412
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2021
• Device Model Number: 9610TF23
• 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
• Date Device Manufactured: 08/28/2019
• 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 Age: 86 YR
• Patient Sex: Female