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

Model Number 9750CM26A

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2023

Event Type  malfunction  

Event Description

During a tavr procedure using a 26mm sapien 3 ultra resilia valve, the commander balloon ruptured at the end of inflation.It was unable to know if the valve was fully deployed during the inflation.The balloon was able to be removed without any complications.The device was discarded at the hospital.

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device was discarded.

Manufacturer Narrative

Correction to h6; type of investigation, investigation findings, investigation conclusion.The 26mm commander delivery system (ds) was not returned for examination.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Imagery was received that showed a radial balloon burst.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.The following instructions for use (ifu) were reviewed: commander delivery system, device preparation manual, and the procedural training manual.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 event of a balloon burst was confirmed by the imagery provided.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis; therefore, a manufacturing non-conformance was unable to be determined.Additionally, a review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.The complaint description states, "the patient had a heavy amount of raphe noted on the ct and had paravalvular leak (pvl) coming through the lcc.2cc-3cc were added and post-dilated with slight improvement.However, the patient still had moderate pvl.The decision was made to deploy a 2nd sapien 3 26 ultra with additional 2cc's.Inflated the commander delivery system and the balloon ruptured at the end of inflation".The balloon burst could be potentially from multiple factors (i.E.Calcified annulus/leaflets, additional inflation volume, and 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.Additionally, it was noted that an additional volume of 2cc was added to the balloon.The prescribed nominal inflation volume is provided in the ifu.It is possible the balloon was overinflated, subjecting the balloon to pressures high enough to cause the balloon to burst.In this case, a review of available information suggests that patient factors (pre-existing valve) and procedural factors (over-inflation) contributed to the balloon burst.However, a conclusive root cause is unable to be determined.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment nor corrective or preventative actions are required at this time.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1edwards 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: 18120370
• MDR Text Key: 327936876
• Report Number: 2015691-2023-17449
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)250727(10)65230730
• 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
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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 Sex: Male