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

Model Number 9600LDS23A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Vascular Dissection (3160)

Event Date 12/02/2017

Event Type  Injury  

Manufacturer Narrative

Thv/tvt registry.(b)(4).Investigation of this event is ongoing.

Event Description

It was reported that a patient with a 23mm edwards surgical valve of unknown model underwent a successful valve-in-valve tf procedure with a 23mm 9600tfx transcatheter heart valve.According to the operative report, upon removal of the esheath, the perclose sutures were all tied with excellent hemostasis.Final right iliac angiography showed unchanged disease in the right external iliac, however there was a right common femoral artery stenosis with dissection and poor flow past the femoral access site.This was treated with peripheral angioplasty at 4 atm in the right femoral as well as right external iliac.The left femoral artery sheath was removed and manual pressure used to obtain hemostasis.Additional information provided by the physician, the vascular injury may be associated with potentially difficult or problematic withdrawal of the delivery system through the sheath.

Manufacturer Narrative

The device was not returned edwards lifesciences for evaluation, as it was discarded at the facility.In this particular case, despite multiple investigational attempts, it was not possible to obtain additional details regarding the reported event.Additional information is not forthcoming.A review of the device history records (dhr) and lot history did not reveal any issues that could have contributed to the reported events.During manufacturing, the delivery system undergoes multiple inspections and testing including: balloon 100% inspection for working length, balloon diameter, proximal and distal leg id, proximal leg od, double wall thickness, and for mechanical damage and deformation.The crimp balloon is 100% inspected for balloon distal and proximal id, wall thickness and defects.The flex tip od is inspected.The balloon size is inspected for balloon size and distorted/pinched folds.100% functional inspection and visual inspections are performed during final inspection.  in addition, the commander delivery system undergoes functional product verification testing on a sampling basis, including retrieval force of system through sheath, and locknut/collect engagement tensile testing.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the reported complaint event.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.Due to the unavailability of the device or any relevant imagery for this specific complaint, the complaint for difficulty during removal of the delivery system was unable to be confirmed.Since applicable devices were not returned, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, it cannot be determined if a manufacturing non-conformance contributed to the complaint event.However, a review of complaint history and manufacturing processes revealed that it is unlikely a manufacturing issue contributed to the complaint.Additionally, a review of ifu/training manuals revealed no deficiencies.Per report, ¿the vascular injuries may have occurred as a result of not properly positioning the flex catheter over the balloon catheter prior to withdrawal.It was considered that the flex tip may not have compressed as intended due to the positioning.¿ if the flex tip was not properly positioned over the triple marker during withdrawal as instructed by the training manuals, the flex tip may have been flared during removal.The inflation balloon has a larger profile that then crimp balloon, so positioning the flex tip over this component could potentially cause flaring of the flex tip.This could have made it more difficult to retrieve the device through the patient¿s vessels and the esheath.However, it is unknown if the delivery system was retrieved with the flex tip over the balloon, or if the balloon shaft slipped during retrieval, causing the flex tip to push up against the balloon.The following scenarios could have occurred to cause the balloon shaft to slip:    the balloon shaft was not fully locked and thus slipped during removal.The training manual instructs that the flex tip should be positioned over the triple marker and the balloon shaft should be locked prior to removal.   the device was locked, but the balloon shaft slipped during removal.It is possible that, if the balloon shaft is being pulled on for delivery system withdrawal, the balloon shaft could have slipped while the flex tip was passing through the seals of the esheath (as this would have provided additional resistance/force during withdrawal).If the balloon shaft slipped, resulting in the flex tip being pushed up against the balloon before the device was withdrawn into the esheath, this could have potentially led to an enlarged flex tip profile and contributed to the reported event.The complaint was unable to be confirmed.  available information suggests that procedural factors may have contributed to the reported difficulties during device removal resulting in vascular injury.However, a definite root cause is unable to be determined at this time.  review of complaint history revealed that the occurrence rate did not exceed the march 2018 control limit for the applicable trend categories.Since no manufacturing non-conformances, labeling, training, or ifu deficiencies were identified, no corrective or preventative action is required 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 92164
• MDR Report Key: 7329426
• MDR Text Key: 102065886
• Report Number: 2015691-2018-00836
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 9600LDS23A
• Device Lot Number: 61014371
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Weight: 61