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

Model Number 9600LDS26A

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Difficult to Remove (1528); Failure to Align (2522)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is ongoing.

Event Description

During implant of a 26mm sapien 3 valve in the native aortic position using transfemoral approach, the 26mm commander delivery system balloon did not inflate and the valve was not deployed.When negative pressure was pulled, blood was seen in the endoflator.The valve was unable to be pulled into the sheath due to the patient¿s tortuous aorta.A cutdown was performed to remove the valve and delivery system.A second valve was planned to be implanted, however, the initial valve was difficult to remove through the cutdown.Thus, the artery was repaired and the procedure was aborted.The patient¿s entire aorta and aortic angle were extremely tortuous and there was a significant amount of tension in the system.There was no straight part of the aorta to align the valve.

Manufacturer Narrative

Correction to h1.Type of reportable event changed to serious injury.The devices were not returned to edwards lifesciences for evaluation.Therefore, visual, functional, and dimensional analysis could not be performed.Review of the patient¿s imagery showed the patient¿s vasculature (access vessels and aorta) exhibited extreme tortuosity.Per the report, the valve alignment was not able to be performed in a straight section of the vasculature due to extreme tortuosity.Performing valve alignment in tortuous vasculature can result in higher forces required to align the valve.Additionally, if the thv is not in a straight section of the aorta during valve alignment, the thv can become unseated/non-coaxial with the flex tip, causing the thv to dive into the flex catheter lumen, and further increase difficulty with valve alignment.The type of leak was not able to be identified.However, available information suggests it occurred after device preparation, as there were no issues with de-airing, and before thv deployment (as the balloon could not be inflated).The leak may have been a result of the device becoming damaged during valve alignment.It is possible that the crimp balloon may tear when exposed to high forces/tension in the system.Retrieval of a crimped thv in tortuous anatomy may cause non-coaxiality between the thv and sheath tip and result in retrieval difficulty.Based on the available information, it is likely that patient/procedural factors (tortuous patient anatomy, performing valve alignment in a non-straight section of aorta) may have contributed to valve alignment difficulties and delivery system leakage.Patient factors (tortuous patient anatomy) may have contributed to the difficulty retrieving the thv into the sheath.During manufacturing of the delivery system, the delivery system and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformances contributed to the reported events.The following were reviewed for instructions/guidance for preparation and use of the devices: the edwards esheath introducer set is contraindicated for tortuous or calcified vessels that would prevent safe entry of the introducer and sheath.Valve alignment: perform valve alignment in the straight section of the aorta.If valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage and inability to inflate the balloon.Delivery system removal: completely unflex the delivery system, ensure flex tip is still over the triple marker, ensure balloon lock is locked, ensure the balloon is completely deflated, pull the entire delivery system through the sheath, maintain guidewire position in the aorta, delivery system removal.Patient injury could occur if the delivery system is not completely unflexed prior to removal.Balloon rupture: if delivery system balloon ruptures or leaks during deployment without thv embolization: do not use excessive force.Take care when crossing the thv, tracking back over the arch and removing the delivery system (through the tip of the sheath).A device history review (dhr) did not reveal any related issues that could have contributed to the reported events.A lot history review revealed no other complaints related to any of the 3 complaint codes selected for this report.A review of the complaint history revealed that the occurrence rate did not exceed the september 2019 control limit for the applicable trend categories.The complaint for ¿delivery system ¿ leakage¿ unable to be confirmed.While a definitive root cause was unable to be determined, the available information suggests that patient factors (tortuous patient anatomy) and procedural factors (performing valve alignment in non-straight section of aorta) likely contributed to the complaint event.The complaint for ¿delivery system, difficulty with valve alignment¿ was confirmed.While a definitive root cause was unable to be determined, the available information suggests that patient factors (tortuous patient anatomy) and procedural factors (performing valve alignment in non-straight section of aorta) likely contributed to the complaint event.The complaint for ¿delivery system, withdrawal difficulty-valve through sheath¿ was confirmed.While a definitive root cause was unable to be determined, the available information suggests that patient factors (tortuous patient anatomy) likely contributed to the complaint event.No manufacturing non-conformance could be determined without device photos and/or device evaluation.A review of the dhr, complaint history, lot history, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.Additionally, a review of the ifu and training manual revealed no deficiencies.Since no product non-conformances or ifu/training manual deficiencies were identified and a review of the complaint history revealed that the complaint rate did not exceed the september 2019 control limit for the relevant trend category, no corrective or preventative actions are required at this time.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS COMMANDER DELIVERY
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9181474
• MDR Text Key: 194611022
• Report Number: 2015691-2019-03761
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2019

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 Expiration Date: 06/09/2021
• Device Model Number: 9600LDS26A
• Device Lot Number: 62356123
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 11/15/2019; 07/23/2020
• Supplement Dates FDA Received: 11/22/2019; 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR