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

Model Number 9600LDS26

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is ongoing, pending the engineering evaluation of the returned device.

Event Description

During a transfemoral tavr procedure, there were difficulties withdrawing the valve within the sheath and a surgical cutdown was performed to remove the devices.The area was repaired with a graft.The patient had severe scoliosis, which made her anatomy tortuous.When aligning the valve in the descending aorta, the sheath experienced some kinking.The initial alignment of pulling the balloon into the valve (the delivery system back to the solid white line) went normal, but when the physician attempted to do the fine adjustment of the valve between the two markers, the delivery system was not responding.The nose cone was across the top of the arch at this point and the balloon was coming back into the valve at an angle, the pusher was at the other end of the valve at an angle as well.The system was reset to release some stored tension and continued to move slowly to align the valve on the balloon.At one point, when moving the fine adjustment knob, nothing was happening to the system, until the balloon suddenly jumped into the middle of the valve.The valve was then in between the markers, so the team decided to apply catheter flex and advance over the arch.Once the valve was across the annulus, the physician went to pull the pusher back.It was a horizontal aorta, and the system flexed to the max, there was additional difficulty pulling the pusher back, so a slight unflex was applied with continued release.Right before the pusher reached the first of the 3 radiopaque markers, it was noticed that the balloon shifted from the center of the valve as well, so that the center marker was close to the top struts of the valve and the bottom marker was in the middle of the valve.When the pusher was moved back to the top of the valve, it pushed the balloon back into the center of the valve.They tried once more to pull the pusher back to the appropriate location, and it once again moved the balloon within the stent.At this point, it was noticed that there was some blood in the flushport of the system and that something was obviously broken/wrong, so it was decided to pull the system out and start from scratch.They attempted to align the pusher flush with the top of the valve to reduce any potential complications going across the arch, in the descending aorta and out the iliacs, but they were unable to get the pusher right up against the valve.The delivery system was slowly advanced back across the arch and they were able to pull the valve, delivery system and sheath back to the common femoral.At that point, it was not possible to easily pull back any further and it was decided to do a cut down to get the valve out.Vascular surgery came in and put in a graft, which was used to deliver a second valve/delivery system.For the second system, it was decided to align within the sheath, so they used the 16fr sheath with the 26mm s3 valve.The alignment in the sheath worked well and the rest of the valve deployment went as it should with only trace leak post deployment.Post procedure, the patient was recovering well and was walking around.

Manufacturer Narrative

The following devices were returned to edwards lifesciences for evaluation: commander delivery system, inserted through the esheath, with the valve crimped on the inflation balloon.The handle was returned in locked position with approximately one inch of fine adjust used.The inflation balloon was completely separated from the crimp balloon proximal to the laser bond between the two components.The inflation balloon was returned with brunching present on the proximal end.The flex tip surface was noted to have ¿gouge marks.¿ compression was noted at the flex shaft to flex tip transition point.Slight bend/pinching of flex shaft proximal to flex tip.No other visual abnormalities were observed.No functional testing could be conducted on the delivery system due to its returned condition (torn crimp balloon).A dhr review performed did not reveal any other manufacturing related issues that could have contributed to this reported event.Review of the complaint history revealed that the occurrence rate did not exceed the (b)(6) 2016 control limits for these trend categories.The reported balloon torn and delivery system withdrawal difficulty through sheath were confirmed based upon the visual inspection of the returned device (torn crimp balloon and flared inflation balloon ¿wings¿).However, no indication of a potential manufacturing non-conformance was identified during the engineering evaluation.A review of manufacturing procedures supported that the balloon and the associated device has proper inspections in place to detect issues related to the balloon torn.The dimensional inspection of the crimp balloon revealed that the wall thickness was within specification, and the bond in this location remained intact.Per the complaint description, the patient has severe scoliosis which made her anatomy tortuous.As a result, valve alignment may have been performed in a bent section of the aorta, contrary to ifu instructions to perform valve alignment in a straight section of the aorta.Performing valve alignment where the delivery system is bent 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.There is visual evidence that this is likely to have occurred since the flex tip was returned with ¿gouge marks.¿ if the thv is unseated during alignment, it can result in higher than usual valve alignment forces, and can potentially cause a tear between the inflation balloon and crimp balloon if excessive force is used to try and achieve final alignment position.An engineering study was previously performed to confirm this condition and was able to recreate high enough forces to potentially cause a material failure in the area in question.Once the inflation balloon and the crimp balloon are torn, it can create difficulties retrieving the delivery system, where the torn inflation balloon and thv may be unable to be retrieved into the tip of the esheath.In addition, tortuous or calcified access vessels can also cause non-coaxial retrieval angles, which can aggravate any difficulties experienced with delivery system retrieval.While a definitive root cause was unable to be determined, available information indicates that the patient anatomy (severe scoliosis which can result in tortuous vasculature) and procedural factors (performing valve alignment in a tortuous portion of the anatomy) may have contributed to the reported event.The reported balloon torn was confirmed.No manufacturing issues were conclusively identified in the returned product during engineering evaluation.No labeling or ifu inadequacies were identified.Per management discretion, product risk assessment was initiated for further assessment of the issue.The reported for delivery system withdrawal difficulty of the valve through sheath was confirmed.No manufacturing issues were conclusively identified in the returned product during engineering evaluation.Available information suggests that procedural factors may have contributed to the event.No labeling or ifu inadequacies have been identified.Review of complaint history revealed that the occurrence rate does not exceed control limits for this trend category.Therefore, no corrective or preventative action is required at this time.No root cause has been determined at this time.

• Brand Name: EDWARDS 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston, rn ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5528444
• MDR Text Key: 41209609
• Report Number: 2015691-2016-00957
• Device Sequence Number: 1
• Product Code: NPT
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2017
• Device Model Number: 9600LDS26
• Device Lot Number: 60220468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2015
• 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: 82 YR