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

Model Number 9750CM29A

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

During an off-label tavr case for pure ai using a 29mm sapien 3 valve via subclavian approach, +7cc to start and the valve began to migrate into the left ventricle shortly after.Several cc's were added after to secure the valve more and the balloon burst.The pressures dropped quickly after.A new valve/system was quickly prepped but was never implanted as it was determined that there was a rupture and the patient wasn't a candidate for opening the chest.The patient passed away.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-18503.The investigation is ongoing.H3 other text : device will not be returned.

Manufacturer Narrative

Correction to h6; type of investigation, investigation findings, investigation conclusion.The 29mm commander delivery system (ds) was not available for examination.Due to the unavailability of the complaint device, engineering could not perform any visual inspection, functional testing, or dimensional analysis.The following instructions for use (ifu) were reviewed: the commander delivery system and the device 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 complaint of balloon burst was unable to be confirmed as no procedural imagery or device was provided for evaluation.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.Due to the unavailability of the device lot number, a review of the dhr and lot history was unable to be performed.A review of the ifu and training manuals revealed no deficiencies.The reported event states, "during an off-label tavr case for pure ai using a 29mm sapien 3 valve via subclavian approach, +7cc to start and the valve began to migrate into the left ventricle shortly after.Several cc's were added after to secure the valve more and the balloon burst".While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressure, there are several factors that could result in balloon burst such as calcification, over-inflation, and interaction with previously implanted valve/stent.In this case, additional volume (+7cc) was initially added, and then several cc's were used to secure the valve.The prescribed nominal inflation volume is provided in the ifu.Based on the provided information, it is possible that the balloon was overinflated, subjecting the balloon to pressures high enough to cause the balloon to burst.While a conclusive root cause was unknown, available information suggests that procedural factors (over-inflation) may have contributed to the balloon burst.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; 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: 18352686
• MDR Text Key: 331062515
• Report Number: 2015691-2023-18516
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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: 9750CM29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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