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

Model Number 9600LDS29A

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

During a tavr procedure using a 29mm sapien 3 valve via transfemoral approach, the implanter could not pull/push the catheter back.The patient had very tortuous aorta and valve alignment was difficult.The decision was made to removed first valve along with the delivery system and sheath.A stiffer wire was used on the contralateral side to make the aorta less tortuous.A new sheath, delivery system, and valve were all implanted successfully valve.The device was returned for examination and a preliminary investigation found that the catheter balloon was torn.

Manufacturer Narrative

The 26mm commander delivery system was returned for evaluation.The preliminary evaluation found that the liner is partially delaminated just proximal to the distal tip, multiple kinks located on the flex shaft, located 1" from the flex tip, 2" from the flex tip, and 3" from the flex tip, a leak was noted on the crimp balloon, crimp balloon is torn at the bond between balloon shaft and crimp balloon, and when at 100% fine adjust (fa), stored tension created curvature in the flex shaft.The 3mensio imagery that was provided showed the presence of tortuosity in the patient's access vessels.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 following instructions for use (ifu) were reviewed: commander delivery system with s3, 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 complaints for resistance, valve alignment difficulty, and balloon leak were confirmed through returned product evaluation.However, no manufacturing non-conformance was identified.Additionally, a review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the reported event.A review of ifu/training materials revealed no deficiencies.As per the event description, "the implanter could not pull push the catheter back".The patient had a very tortuous aorta and was difficult to do valve alignment.It would not fully align once starting with fine adjustment.The tear likely happened during valve alignment due to the tortuous nature of the vessels.The event description stated, "the implanter could not pull push the catheter back.The patient had very tortuous aorta" and the provided imagery revealed tortuosity in the access vessels.If there is tortuosity present in the vasculature, it may be difficult to move the balloon shaft through bends in the anatomy.Also, it is possible that navigating the delivery system through a tortuous anatomy can result in built-up tension in the system.If tension is not released, it is possible that the tension may have increased resistance between the shafts.The patient had a very tortuous aorta and there were minor flex tip gouges.Therefore, it is possible that if valve alignment was performed in a tortuous vasculature (non-straight section), this could have caused the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and "dive" into the flex tip.If the thv was unseated from the flex tip during alignment, it could have resulted in higher-than-normal alignment forces creating high tension in the system, which could have consequentially led to the reported valve alignment difficulties.Additionally, excessive manipulation may have been used due to the increased valve alignment forces may have resulted in the valve's interaction with the balloon, causing the valve to compromise the balloon structure, subsequently leading to balloon leakage.In this case, available information suggests that patient factors (tortuosity) and/or procedural factors (valve alignment in the non-straight section, excessive manipulation, and built-up tension) contributed to the valve alignment difficulty and balloon leakage.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.

Event Description

Additional information provided indicated that the tear in the balloon likely happened during valve alignment due to the tortuous nature of the vessels.

• 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: 18049911
• MDR Text Key: 327096603
• Report Number: 2015691-2023-17188
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)250410(10)65001206
• 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: 12/18/2023

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: 9600LDS29A
• Device Lot Number: 65001206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 12/16/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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 Age: 86 YR
• Patient Sex: Male