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

Model Number 9600LDS23J

Device Problem Deflation Problem (1149)

Patient Problem Ventricular Fibrillation (2130)

Event Date 07/26/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

During the transfemoral tavr for a 23mm sapien 3 valve, the inability to deflate the balloon occurred.Due to the event, rapid pacing time was prolonged and ventricular fibrillation (vf) occurred.After the valve implantation, post-dilation was executed to resolve the moderate paravalvular leak (pvl).The delivery system (ds) was re-inserted and when post-dilation was executed, the operator complained of strong resistance in atrion inflation device.After the post-dilation 1ml less than nominal volume was executed and the balloon was unable to be deflated.The three-way stopcock was removed from the inflation port of ds to attach the 50ml syringe; however, the balloon would not deflate.Negative pressure was applied for about 30 seconds and gradually the contrast agent was withdrawn into the syringe.When half of the balloon was deflated, the balloon was able to be removed from the annulus.When the rapid pacing was stopped, vf occurred.Defibrillation resolved the vf and hemodynamics became stable.The pvl was reduced to mild.The patient awakened and extubated, the level of consciousness was normal, and the patient was transferred to icu.After the procedure, the ds was tested and there was no trouble with inflation and deflation.Also, there was no abnormalities noted in three-way stopcock or the atrion device.

Manufacturer Narrative

Correction to h6; component code, type of investigation, investigation findings, investigation conclusion.Correction to g1, added japan.The commander delivery system (ds) was returned for examination.The complaint for balloon deflation was unable to be confirmed as the complaint could not be recreated during the evaluation of the returned device.Visual examination found a kink on the distal balloon and wrinkles on the inflation balloon with no other abnormalities noted.3mension imagery was provided that showed the patient had a horizontal aorta and there was tortuosity and calcification of the abdominal aorta.Functional testing was performed, and the following were observed; during pre-contamination testing, the balloon was able to be inflated and deflated using the provided atrion inflation device with no issue.During post-decontamination testing of the balloon was found it met specifications when inflating and deflating.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint 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 with s3 ifu, commander with s3 device preparation manual, and procedural training manual.Based on the review, no ifu or 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 for balloon deflation was unable to be confirmed as the complaint could not be recreated during the evaluation of the returned device.However, 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.As reported, "after the post-dilation 1ml less than nominal volume was executed, the balloon was unable to be deflated.The three-way stopcock was removed from the inflation port of commander to attach the 50ml syringe; however, the balloon was not deflated.Negative pressure was applied for about 30 seconds.Gradually the contrast agent was withdrawn into the syringe.When the balloon was deflated about half, the balloon was able to be removed from the annulus." additionally, the complaint description mentions, "after the procedure, the commander was tested and there was no trouble in inflation and deflation," suggesting that the complaint events likely occurred due to patient or procedural factors.Evaluation of the returned device noted a kink on the proximal balloon catheter at the default marker.Additionally, 3mensio provided showed tortuosity and calcification present in the patient's vasculature.The observed horizontal aorta, other vascular tortuosity, and calcification present can make the pathway more challenging as the delivery system can torque as it tracks through the anatomy.Torquing of the delivery system can result in an obstructive pathway that may have led to reported deflation difficulty.Additionally, while no difficulty advancing or tracking the delivery system was reported, it is possible that excessive force applied during device insertion or tracking could have caused the delivery system to kink.A kinked balloon shaft may constrain the guidewire lumen and affect the rate at which the balloon is able to be fully deflated, leading to the reported deflation difficulty.In this case, a conclusive root cause was unable to be determined, however available information suggests that patient (calcification, tortuosity) and procedural factors (excessive manipulation, kinked balloon shaft) may have contributed to the reported event.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.No corrective or preventative actions are required.

Manufacturer Narrative

Correction to h6; investigation conclusion.A supplemental report is being submitted as the root cause section has been corrected.As reported, "after the post-dilation 1ml less than nominal volume was executed, the balloon was unable to be deflated.The three-way stopcock was removed from the inflation port of commander to attach the 50ml syringe; however, the balloon was not deflated.Negative pressure was applied for about 30 seconds.Gradually the contrast agent was withdrawn into the syringe.When the balloon was deflated about half, the balloon was able to be removed from the annulus." additionally, the complaint description mentions, "after the procedure, the commander was tested and there was no trouble in inflation and deflation," suggesting that the complaint events likely occurred due to patient or procedural factors.The 3mensio provided showed tortuosity and calcification present in the patient's vasculature.The observed horizontal aorta, vascular tortuosity, and calcification present can make the pathway more challenging for the delivery system (ds) to navigate.During the product evaluation, the crimp balloon was found slightly twisted, and this may have occurred while the ds tracked through the anatomy.If the crimp balloon is twisted, it can impede the fluid pathway leading to inflation/deflation difficulty, as reported in this case.A conclusive root cause was unable to be determined, however available information suggests that patient factors (calcification, tortuosity) may have contributed to the reported event.

• 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: 15240754
• MDR Text Key: 298049909
• Report Number: 2015691-2022-07371
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194869
• UDI-Public: (01)00690103194869(17)240320(10)64297314
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2024
• Device Model Number: 9600LDS23J
• Device Lot Number: 64297314
• 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: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• 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 Age: 89 YR
• Patient Sex: Female