MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF26

Device Problems Difficult or Delayed Positioning (1157); Inflation Problem (1310); Difficult to Remove (1528); Retraction Problem (1536); Failure to Align (2522)

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

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our (b)(6) affiliate, during a transfemoral valve in surgical valve procedure with a 26mm sapien 3 valve in the aortic position, valve alignment difficulty was encountered.The initial valve alignment movements were performed inside the sheath.  the final movements of valve alignment were done outside the sheath. at the time of the implant, the commander delivery system balloon failed to inflate.The valve was not able to be retracted into the sheath for removal.The sheath was partly removed, with the undeployed valve still mounted on the delivery system. a decision was made to perform an open procedure and surgically remove the valve from the descending aorta.The delivery system was successfully surgically removed.The patient is stable.The patient¿s access vessel minimum luminal diameter (mld) measured 8mm with moderate calcification and moderate tortuosity.The device will be returned for evaluation.

Manufacturer Narrative

Add product problem the commander delivery system was returned to edwards lifesciences for evaluation.Visual inspection of the delivery system revealed the following: the distal portion of the balloon catheter was cut (proximal centering marker/nose tip), the balloon spring material is cut, crimp balloon material is torn (proximal to the i/c bond), gouging observed on the flex tip, inflation balloon in cut pieces (no balloon pieces are missing), thv on working length of balloon, and balloon bunched at the distal end of the working length.Procedural photos and imaging were provided and revealed that the valve was partially aligned on the balloon shaft while remaining in the sheath, the valve was positioned in the annulus and the valve was not centered between the alignment markers of the balloon.Functional testing on the collet engagement force was measured and was found to be within engineering specification.In addition, during evaluation of the delivery system, the system was able to be pulled to the valve alignment marker and locked.Full valve alignment including both gross and fine adjust was able to be performed.Dimensional testing was performed on the double wall thickness of the crimp balloon proximal to the tear and were found to be within specification.During manufacturing, visual inspections and tests are performed throughout the process.Per procedure, the balloon is visually and dimensionally inspected.During crimp balloon final inspection, the crimp balloons are 100% visually inspected.Per procedure, during final inspection the delivery system is 100% visually and functionally tested distal to proximal by both manufacturing and quality.During crimp balloon to inflation balloon laser bonding, the laser weld joint is 100% visually inspected.Per procedure, the form balloon is inspected for damage.The commander delivery system is 100% leak tested.In addition, product verification (pv) testing is performed on a sampling basis for physical defects, and tensile testing on the inflation balloon/crimp balloon.The lot met statistical requirements as requirement for lot released.These inspections support that it is unlikely that a defect present in manufacturing contributed to the complaints.A device history record (dhr) was reviewed and no manufacturing non-conformances were identified that would have contributed to the event.The lot history was performed for the reported complaints and related complaints were found.Available information suggests that the balloon torn was related to patient/procedural factors.A review of the complaint history from october 2018 to september 2019 revealed other returned complaints for commander delivery system related to the reported events (all models and sizes).However, no manufacturing non-conformances were identified during the investigations of the similar complaints.Available information suggests that patient and/or procedure factors contributed to the events.A review of complaint history revealed that the occurrence rate did not exceed the september 2019 control limit for all the trend categories.The ifu and procedural training manual were reviewed for instructions/guidance relevant to proper device handling.The procedural manual provides guidance on valve alignment.Factors that can assist in valve alignment are as follows: perform valve alignment in the straight section of the aorta, unlock, pull the balloon catheter straight back at the y-connector until part of the warning marker is visible and lock, do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure, check delivery system before valve alignment.If kinked, do not use, slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap, compression may be observed in the distal portion of the flex catheter during valve alignment, and diving may be observed between the thv and flex catheter tip during valve alignment.To correct difficulty with valve alignment: move to a different straight section of the aorta (for diving only), if using the balloon catheter, push forward slightly and then continue pulling back until part of warning marker is visible, and if using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.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.Utilizing alternate fluoroscopic views may help with assessing curvature of the anatomy.If excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the aorta and relieving compression (or tension) in the system will be necessary.The procedural manual provides guidance on thv retrieval through sheath and delivery system balloon ruptures or leaks during deployment without thv embolization: the thv can be retrieved through sheath only before thv deployment (still crimped), ensure the thv is centered on the flex tip, ensure delivery system is locked, verify the flex catheter is completely unflexed, retract the thv and delivery system into the sheath ensuring the thv is completely inside the sheath and just past the sheath tip, ensure the edwards logo on the sheath handle is facing upward, withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position, and do not re-use the sheath, thv or delivery system once thv is retrieved.Note: the crimped thv aligned on balloon is larger than crimped thv off balloon.Take care if deciding to retrieve and do not force the thv into the sheath.If resistance is felt, the thv may be caught on the sheath tip.Stop, advance thv past the sheath tip and ensure thv is centered on the flex tip.Rotate the delivery system before trying again.If the balloon ruptures or leaks during deployment, 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), maintain guidewire position, check for pv leaks under echo and if post-dilation needed, use a new delivery system.No ifu or training deficiencies were identified.The complaints were confirmed based on visual inspection of the returned device.Investigation of the device, review of lot history, dhr and complaint history revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.As identified in a product risk assessment, high valve alignment forces can be a potential root cause for separation of the crimp balloon material proximal to the inflation balloon to crimp balloon bond.If the physician performed valve alignment in a tortuous anatomy, it may have resulted in increased forces being applied to the bond area.Additionally, if the thv is at a bend or angle during alignment, this can cause the thv to unseat (non-coaxial placement of valve in relation to the flex tip) from the flex tip during alignment and ¿dive¿ into the lumen of the flex tip, where part of the crimped valve slides into the flex tip lumen.If the thv is unseated during alignment, it can result in higher than usual valve alignment forces and can potentially weaken the bond between the inflation balloon and crimp balloon.The flex tip gouges observed during visual inspection is indicative of some level of non-coaxiality of the valve against the flex tip.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high enough valve alignment forces to potentially cause a material failure in the area in question.It was noted in the complaint description that ¿the straightest portion of the descending aorta was used, however the aorta was tortuous and i would not describe the section used for balloon alignment as straight¿.Review of provided imagery indicating the valve partially aligned inside the sheath supports the information provided that ¿the gross alignment was performed within the sheath because of tortuosity in the aorta¿.Aligning the valve while inside the sheath may have contributed to high valve alignment forces and balloon damage as the sheath restricts the movement of the valve, similar to performing valve alignment in a constrained vessel.In addition, per report, the patient had moderately tortuous and calcified access vasculature and a tortuous aorta.Tortuous anatomy can cause the valve to be off axis from the sheath, contributing to the withdrawal difficulty.Additionally, as suggested by the flared-out balloon legs, it is possible that the balloon legs had gotten caught on the sheath tip during retrieval.In this case, available information suggests that patient factors (descending aorta tortuosity and vascular tortuosity/calcification) and procedural factors (high alignment forces as a result of valve alignment in non-straight section/valve alignment conducted within the sheath and retrieval of the torn balloon) may have contributed to the events for difficulty with valve alignment and withdrawal difficulty.However, a conclusive root cause is unable to be determined.No labeling or ifu/training inadequacies have been identified.Review of the complaint history revealed that the occurrence rates did not exceed the september 2019 control limits for the applicable trend categories.As such, no corrective or preventive action is required.In addition, the balloon torn reported events and its associated risks have been previously been assessed and documented in a product risk assessment (pra) and a cap was previously initiated to address the issue.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9100657
• MDR Text Key: 162313818
• Report Number: 2015691-2019-03530
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2019

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: 03/26/2021
• Device Model Number: 9610TF26
• Device Lot Number: 62083344
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 11/27/2019; 07/23/2020
• Supplement Dates FDA Received: 12/02/2019; 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR