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

Model Number 9610TF23U

Device Problem Material Rupture (1546)

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

Event Date 12/05/2023

Event Type  malfunction  

Event Description

As reported by an edwards lifesciences affiliate in france, regarding a 23mm sapien 3 ultra valve in aortic position by transfemoral approach.During the procedure, at the end of deployment with nominal volume, the 23mm commander delivery system balloon burst.The valve was correctly implanted at correct position and fully expanded.The delivery system was retrieved through the esheath with no difficulties.The patient did not suffer any injury and was noted as to have no impact due to the event.

Manufacturer Narrative

Investigation is underway.H3 other text : not returned.

Manufacturer Narrative

The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was returned for evaluation.The returned device was visually examined, and the following was observed: balloon longitudinal and radial burst at 40 cm from nose tip.Due to the nature of the complaint (balloon burst), no functional testing was able to be performed.The complaint was confirmed through visual examination.The inflation balloon single wall thickness was measured along the edges of the burst location.All measurements taken of the balloon single wall thickness met the specification.Per the technical summary, 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 reported event was confirmed based on evaluation of the returned device.Available information suggests that patient factors (calcification) likely contributed to the event as the provided information mentioned presence of calcification in patients native valve.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.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 ; 9492506384
• MDR Report Key: 18365853
• MDR Text Key: 331318313
• Report Number: 2015691-2023-18592
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF23U
• Device Lot Number: 65181532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2023
• 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