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

Model Number 9610TF29

Device Problem Burst Container or Vessel (1074)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

As reported from our edwards lifesciences affiliate in germany, during the transfemoral transcatheter aortic valve replacement (tavr) procedure with a 29 mm sapien 3 valve, during inflation of the commander delivery system balloon when the valve was fully deployed, the balloon burst.The delivery system was able to be withdrawn from the patient without any issues.The procedure was determined to be successful with good implantation and expansion of the valve.The patient was stable.

Manufacturer Narrative

The investigation is ongoing.H3 other text : pending device return.

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 to edwards lifesciences for evaluation.Visual inspection of the returned device revealed a longitudinal burst at the working length of the inflation balloon.A dimensional testing was also performed.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.Imagery was received for evaluation.Review of the imagery revealed presence of calcification at the annulus and left ventricular outflow tract (lvot).Per the technical summary, the instructions for use (ifu), current risk mitigations including 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 balloon burst was confirmed per evaluation of the returned device.The available information suggests that patient factors (calcification) likely contributed to the event as there was presence of annular and lvot calcification per imagery received.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested, calcified nodules can compromise the structure of the balloon wall via the 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: 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: 18247471
• MDR Text Key: 329494446
• Report Number: 2015691-2023-17838
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Device Lot Number: 65157205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• 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