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

Model Number 9610TF26U

Device Problem Inflation Problem (1310)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

As reported by an edwards (b)(4) affiliate, during a transfemoral tavr procedure with a 26mm sapien 3 ultra valve, during valve deployment, the balloon partially inflated proximally, resulting in a 'cone' shaped valve.The balloon was deflated and re-inflated with great outcome.There was no harm to the patient.Per report, the valve was between the markers, and did not move from its position.There was no difficulty inflating the device and no damage to the devices.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.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 lot history review was performed and revealed no other complaints relating to the reported event were identified.The complaint for inflation difficulty and/or incomplete inflation was unable to be confirmed as neither the complaint device nor applicable imagery were returned for evaluation.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non conformance was unable to be determined.As reported, 'balloon partially inflated proximally.Resulting on a 'cone' shaped valve.Immediately the balloon was deflated and re-inflated with great outcome.Not harm to patient, with gradient < 10.Trace central pvl.Interventionist puzzled by balloon inflation anomality but satisfied with outcome ' valve was between markers, did not move from its position, there was no difficulty inflating the device and no damage to the devices.' as no relevant imagery was provided, a definite root cause is unable to be determined at this time.However, patient factors such a tortuosity and calcification can contribute to the reported event by presenting challenging pathways and constricting the passageway for the delivery system and may contribute to inflation difficulties.However, without applicable procedural imagery, a definitive root cause is unable to be determined.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.

Manufacturer Narrative

Correction to h6 and h10 based on additional engineering investigations.The event reported is 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 complaint for incomplete inflation was confirmed through empirical evidence (similarity of reported events).Investigation shows that the reported event may be related to device interactions resulting from a potential sheath distal tip torn.A capa has been initiated to capture further investigation and any possible corrective/preventative action activities associated with device interactions resulting from a potential sheath distal tip torn.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.

• 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: 15738218
• MDR Text Key: 305884179
• Report Number: 2015691-2022-09020
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2024
• Device Model Number: 9610TF26U
• Device Lot Number: 64284530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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