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

Model Number 9600LDS29A

Device Problems Kinked (1339); Difficult to Remove (1528); Torn Material (3024)

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

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is ongoing.

Event Description

As reported, during a transfemoral tavr procedure in the aortic position, while trying to inflate the valve, the balloon became ¿separated at the weld point (between balloon and catheter)¿ due to the patient's moderately tortuous aorta.The balloon did not inflate at all.Bav had been performed.The delivery system/valve were removed without surgical intervention.A second delivery system/valve were prepped and the valve was able to be deployed in an 80:20 aortic position with no residual pvl or cai.The patient left the procedure in a stable position.

Manufacturer Narrative

The delivery system was returned to edwards lifesciences for evaluation.The device underwent visual and functional analysis.During visual analysis, the crimp balloon was observed to be torn near its bond to the inflation balloon.Minor gouges were observed to be present on the flex tip.Damage was noted on the flex shaft, approximately 7 inches from the flex tip.Due to the condition of the returned device (balloon torn), no functional testing was able to be performed.The complaints were confirmed by visual inspection.Dimensional analysis was performed.Double wall thickness measurements were taken on the crimp balloon along the balloon separation.The area distal to the tear could not be measured as that area consists of the bond area and inflation balloon.The measurements meet the double wall thickness specification of minimum.The flex shaft outer diameter distal and proximal to the kink was also measured.The measurements meet the outer diameter specification.During the manufacturing process, the entire delivery system (including the crimp balloon inflation balloon, and nose tip) undergoes multiple 100% inspections for general specification for s3 balloons, crimp balloon molding process, crimp balloon to inflation balloon laser bond, balloon catheter laser bond prep, balloon pleat, fold, & forming, final inspection and flex catheter and balloon catheter leak test.Additionally, the work order underwent product verification testing as a requirement for lot release: commander: functional product verification testing and commander: tensile product verification testing.Lot samples were taken for testing.Of note, no failures occurred during product verification testing and the lot was released.These inspections support that it is unlikely that a defect present in manufacturing contributed to the complaint.A device history records (dhr) review performed revealed no issues that would have contributed to the complaint events.Review of history for revealed no additional complaints for ¿balloon ¿ torn¿, ¿flex shaft ¿ kinked, bent¿, or ¿delivery system ¿ withdrawal difficulty, valve through sheath¿.A review of the complaint history from march 2017 to february 2018 revealed 49 other returned complaints for the edwards commander delivery system (9610tf and 9600lds, all sizes) for ¿balloon ¿ torn¿.With 45 of the complaints, no manufacturing non-conformances that would have contributed to the complaint were identified.Four of the complaints are pending engineering evaluation.A review of the complaint history reveals that the occurrence rates did not exceed the february 2018 control limits for the trend category of ¿damaged¿ for the commander delivery system.A review of the complaint history from march 2017 to february 2018 revealed 15 other returned complaints for the edwards commander delivery system (9610tf and 9600lds, all sizes) for ¿delivery system ¿ kinked, bent¿.A review of the complaint history reveals that the occurrence rates did not exceed the february 2018 control limits for the trend category of ¿kinked, bent¿ for the commander delivery system.With 14 of the complaints, the complaints were confirmed, but no manufacturing non-conformities were found.One (1) is pending engineering evaluation.A review of the complaint history from march 2017 to february 2018 revealed 15 other returned complaints for the edwards commander delivery system (9610tf and 9600lds, all sizes) for ¿delivery system ¿ withdrawal difficulty, valve through sheath¿.With all 15 complaints, the complaints were confirmed, but no manufacturing non-conformities that would have contributed to the complaints were identified.A review of the complaint history reveals that the occurrence rates did not exceed the february 2018 control limits for the trend category of ¿withdrawal difficulty¿ for the commander delivery system.The instructions for use and the physician¿s training manual were reviewed for guidance related to the reported event.No ifu/ training deficiencies were identified.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.The complaints for ¿balloon ¿ torn¿, ¿delivery system, kinked, bent¿, and ¿delivery system ¿ withdrawal difficulty, valve through sheath¿ were confirmed based upon the visual inspection of the returned devices.Dimensional testing of the crimp balloon double wall thickness met specification and visual inspection of the device did not reveal a manufacturing non-conformance.Furthermore, review of available information (complaint history, lot history, and dhr) was unable to identify any evidence of manufacturing non-conformances.A review of manufacturing mitigations supports that the balloon and delivery system have proper inspections in place to detect issues related to the complaint event.A review of complaint history revealed that potential root causes for separation of the crimp balloon material proximal to the inflation balloon to crimp balloon bond have been identified and documented in a pra.If the physician performed the valve alignment process in a tortuous anatomy, it may have resulted in increased forces being applied to the crimp balloon.This may occur as 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.If the thv is unseated during alignment, it can result in higher than usual valve alignment forces which may result in a crimp balloon tear.It should be noted that severe gouges were observed on the flex tip of the returned device, which are indicative of high valve alignment forces and valve diving.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.In addition, residual volume left in the balloon may also contribute to increased forces during valve alignment or delivery system retrieval, which could lead to a balloon tear.Another previously performed engineering study was able to recreate high enough valve alignment forces to potentially cause a material failure in the area in question.Once the balloon tore, difficulty may have been encountered when retrieving the balloon into the sheath.Withdrawal of a torn balloon can cause the inflation balloon legs to become stuck on the tip of the sheath during removal.Additionally, the separated legs of the inflation balloon can become bunched or folded during withdrawal through the sheath, increasing the difficulty of removing the system.The legs of the inflation balloon were flared outwards on the returned device, suggesting that they may have become caught on the sheath during removal.It is also possible that the crimped valve became caught on the sheath tip.The withdrawal difficulty is also evident in the damage at the sheath distal tip.Manipulation of the device to overcome the withdrawal difficulty may have contributed to the observed kink in the flex shaft.As a result, the root cause for the reported complaint events can likely be attributed to patient and/or procedural factors.No manufacturing or ifu/training inadequacies were identified.Available information suggests that patient and/or procedural factors may have contributed to the complaint events.No corrective or preventive actions are required at this time.A pra was previously initiated to document and assess the balloon torn issue and its associated risks.

• 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
• MDR Report Key: 7308092
• MDR Text Key: 101478217
• Report Number: 2015691-2018-00705
• 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
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/08/2019
• Device Model Number: 9600LDS29A
• Device Lot Number: 60928221
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR