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

Model Number 9610TF29

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards european affiliate, during a transfemoral tavr procedure in the aortic position, the physician reported resistance while pushing the 29mm (b)(6) 3 valve/commander delivery system through the esheath.Difficulties were then encountered during valve alignment.There was severe resistance while pulling the balloon catheter back and fine adjustment was not working properly.After several attempts and releasing tension a few times it was finally managed to get the valve between the markers.The commander delivery system was advanced and the valve was placed in the annulus.The valve was deployed but it seemed as the valve was not fully expanded.After the balloon was deflated it was seen that blood was aspirated in the atrion syringe.The commander delivery system was removed without issues and a new commander delivery system was taken in order to fully expand the valve.The valve was well implanted and the patient is doing well.The commander was inspected after removal and it was seen that there was a perforation in the balloon.

Manufacturer Narrative

The delivery system was returned to edwards for evaluation.During preliminary evaluation, the delivery system was observed to have a slight compression on the flex tip.A kink on the balloon shaft was observed due to packaging.The warning marker was able to be pulled and full fine adjust was able to be used.A pinhole was observed on the balloon over the triple marker.Investigation is ongoing.

Manufacturer Narrative

In addition to the visual analysis performed, the delivery system also underwent functional and dimensional analysis.During functional analysis, the delivery system was able to be pulled to the valve alignment marker and locked.Full fine adjust and flex were able to be used without any observed abnormalities.During inflation of the balloon, a pinhole leak was noted on the crimp balloon at the triple markers.During dimensional analysis, crimp balloon double wall thickness measurements were taken to ensure that the wall thickness of the material was within specification as a thin wall could contribute to the observed pinhole.All measurements met specification.During manufacturing the delivery system undergoes multiple 100% inspection.Additionally the lot undergoes product verification testing.These inspections support that it is unlikely that a defect present in manufacturing contributed to the complaint.Delivery system ¿ difficulty with valve alignment / handle ¿ fine adjust difficulty the complaints for valve alignment difficulty and fine adjust difficulty were confirmed.If tension builds in the delivery system prior to and/or during valve alignment, the forces required to pull to align the valve and perform fine adjustment can increase.Although information regarding access vessel characterization was not provided, the complaint description states that ¿there was resistance while pushing the commander and valve through the e-sheath¿, which could be attributed to navigation of the delivery system through tortuous access vessels.This navigation along with torquing or manipulation of the system can both lead to an increase of tension in the system, ultimately increasing the difficulty of valve alignment.One indicator that the system is under tension is if compression is noted along the flex shaft during alignment.During visual inspection of the returned device, minor compression of the flex shaft was observed, which is likely because the system was under tension sometime during the procedure.The physician training manual provides tips for how to correct for compression, including pushing the balloon catheter forward or reversing the fine adjustment wheel briefly.The goal of these processes is to relieve tension in the system in order to facilitate additional valve alignment.The complaint description notes that several attempts of releasing tension were performed.The complaint description also revealed that ¿there was severe resistance while pulling the balloon catheter back and fine adjustment was not working properly¿.During functional testing of the returned device, the device was able to be pulled to the warning marker, suggesting that patient/procedural factors may have contributed to the inability to perform valve alignment.Performing valve alignment at a bend or angle 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.Visual inspection of the returned device revealed gouges on the flex tip suggesting diving and/or resistance against the valve struts occurred during the procedure.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.In addition, residual volume left in the balloon may also contribute to increased forces during valve alignment.This was also recreated in a previously performed engineering study.While a definitive root cause was unable to be determined, available information supports that patient/procedural factors may have contributed to the reported complaint.Balloon ¿ leakage the complaint for balloon leakage was confirmed.If the thv is unseated during alignment, it can result in higher than usual valve alignment forces, and can potentially contribute to a weakening of the material around the inflation balloon and crimp balloon (i/c) bond if excessive force is used to try and achieve final alignment position.Gouges on the flex tip are indicative of valve diving and non-coaxially of the system.Several attempts at valve alignment were performed including additional maneuvering of the system to relieve tension, all of which could contribute to damage to the crimp balloon.Dimensional testing indicates that the crimp balloon where the pinhole was observed met specification and no issues were noted during de-airing, thus the crimp balloon damage likely occurred during the procedure.While a definitive root cause was unable to be determined, available information supports that procedural factors may have contributed to the reported complaint.No manufacturing or ifu/labeling inadequacies were identified.Available information suggests that patient and/or procedural factors may have contributed to the events.Review of complaint history revealed that the occurrence rate did not exceed the august 2017 control limits for the failure modes.Therefore, no corrective or preventative action is required.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 6836571
• MDR Text Key: 84640774
• Report Number: 2015691-2017-02725
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/25/2017

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 Expiration Date: 03/09/2019
• Device Model Number: 9610TF29
• Device Lot Number: 60808355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 09/13/2017; 10/05/2017; 11/17/2017
• Supplement Dates FDA Received: 10/05/2017; 10/06/2017; 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• 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: 82 YR