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

Model Number 9610TF26U

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in the (b)(6), this was an aortic valve-in-valve case of a 26mm sapien 3 ultra transcatheter heart valve inside a 25mm perimount surgical valve which failed over time due to stenosis and high degree of calcification.During the procedure, the commander delivery system balloon burst due to the presence of calcium.The valve was fully expanded.Upon pulling out the delivery system, the nose cone and half of the balloon became detached from the commander; this piece remained on the safari wire.This piece was snared and tied to be pulled back into the 14f esheath; however, this was unsuccessful with vascular surgery bail out needed.The patient was reported to be doing fine and ready for discharge.

Manufacturer Narrative

The returned device was evaluated, and the following was observed: the balloon burst confirmed, radial and longitudinal tear.No missing balloon pieces.The distal tip and guidewire lumen were separated.The separated inflation balloon returned bunched.Due to the nature of the complaint, no functional testing was able to be performed.The complaint was confirmed through visual inspection.The inflation balloon single wall thickness was measured along the edges of the burst location.A thickness deviating from the specification could be indicative of an issue during manufacturing of the component, as a thin wall could contribute to the observed burst.All measurements taken of the balloon single wall thickness met the specification.A review of the risk management documentation was performed, and 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.The complaints for balloon burst, withdrawal difficulty, and distal tip separation were confirmed by visual inspection of the returned device as well as returned imagery.However, no manufacturing non-conformance was identified during the evaluation.Dimensional inspection of the returned balloon revealed that the balloon wall thickness was within specification.No visual abnormalities were observed on the returned sample.An existing technical summary has been documented for root cause analysis on balloon bursts in a calcified landing zone.A detailed root cause analysis for similar returned balloon burst complaints has been summarized in a technical summary.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event, including factors on why deployment of balloons on thv delivery systems are subject to increased risk of burst in a calcified landing zone.There was "mod/severe" calcification on landing zone.Additionally, as per medical opinion, the burst was due to calcification.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation 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.As the balloon was burst, the altered balloon profile can be more susceptible to catch on the distal end of sheath tip which would have then led to the experienced retrieval difficulty.As a result, additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.Review of available information suggests that patient factors (calcification) contributed to the balloon burst while procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the withdrawal difficulty and separation.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13426237
• MDR Text Key: 284972218
• Report Number: 2015691-2022-03756
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2023
• Device Model Number: 9610TF26U
• Device Catalogue Number: N/A
• Device Lot Number: 64027838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2021
• 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 Outcome(s): Required Intervention