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

Model Number 9750CM26A

Device Problems Material Fragmentation (1261); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

Per the field clinical specialist (fcs), during a tavr procedure (inside a pre-existing surgical valve) using a 26mm sapien 3 ultra valve via transfemoral approach, the balloon ruptured radially during deployment and the team was unable to pull it back inside the sheath.It needed to be snared from the contralateral side to be removed.The balloon separated when they were trying to pull it out the ipsilateral side.The 14fr esheath began to spilt as the team attempted to remove the balloon.The balloon separated when they were trying to pull it out the ipsilateral side.The device was discarded at the hospital.

Manufacturer Narrative

Correction to h6; device code.Imagery provided and reviewed showed that the commander delivery system balloon shaft with a fully circumferential radial balloon burst at the proximal inflation balloon shoulder.The working length of the inflation balloon is separated and visible.The distal balloon assembly, including the nose tip and guidewire lumen, is fully separated and not visible.Stretching of proximal balloon spring visible.

Manufacturer Narrative

The 26mm commander deliver system (ds) 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.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the complaint code.The commander delivery system ifu, and the procedural manual (ifu) were reviewed.Based on this review, no ifu training deficiencies were identified.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.The reported events were confirmed based on objective assessment.From the information provided, the balloon was fully inflated (with nominal volume) during valve deployment before it burst.The burst could have been due to interaction with calcified annulus/leaflets and/or previously implanted valve.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressure, interaction with rigid calcium nodules or the pre-existing valve can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.Nevertheless, a conclusive root cause cannot be determined as neither imagery that showed the landing zone calcification nor interaction between the inflation balloon and pre-existing valve had been provided.Although relevant imagery is absent and the calcification degree unknown, the event description confirmed the procedure was valve-in-valve.In this case, patient anatomy (pre-existing valve) is the most likely root cause for the balloon burst.The complaint for withdrawal difficulties was confirmed based on the provided imagery.Available information suggests procedural factors (withdrawal of burst balloon) likely contributed to the event as the separation of the distal balloon assembly from the commander delivery system balloon shaft is indicative of the withdrawal forces acting on the balloon.As the balloon burst, the altered balloon profile could have made it more susceptible to catching on the distal end of the sheath tip, which would have then led to the experienced retrieval difficulty.The complaint for distal tip and balloon separation was confirmed based on the provided imagery.Available information suggests procedural factors (withdrawal of burst balloon, excessive manipulation) likely contributed to the event as the event description stated the component separation occurred during the snaring process.As the balloon burst, the altered balloon profile could have made it more susceptible to catching on the distal end of the sheath tip or patient vasculature, which would have then led to the experienced retrieval difficulty.Additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.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: 19004299
• MDR Text Key: 339232458
• Report Number: 2015691-2024-02446
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)251031(10)65403573
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Device Lot Number: 65403573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/09/2024; 05/02/2024
• Supplement Dates FDA Received: 04/16/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male