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

Model Number 9610TF29

Device Problems Positioning Failure (1158); Failure to Align (2522); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) investigation is ongoing.

Event Description

As reported, 29mm sapien 3 case by transseptal approach in mitral position inside a pre-existing valve.Issues were encountered during valve alignment in the vena cava inferior.The system had severe tension and twisted while attempting to get the valve between the markers, therefore it was decided to remove the commander and prepare a new system.With the new commander and valve the implantation was successfully completed.As per pre-deco evaluation, the crimp balloon was torn.

Manufacturer Narrative

Udi: (b)(4).The delivery system was returned to edwards lifesciences for evaluation after use in the procedure.The delivery system was inserted through a sheath and a valve was crimped and positioned partially over the inflation balloon.Imagery provided includes cine of the valve partially aligned on the delivery system.Severe tension in the system, indicated by the kink in the flex catheter and on the balloon spring.The distal end of the balloon is curved, suggesting curvature of the anatomy at the site of valve alignment.The delivery system was visually inspected.There was compression at distal flex shaft, flex tip gouges and the crimp balloon was radially torn.The balloon shaft was able to be pulled to valve alignment position and locked.Full fine adjust was then able to be used with no abnormalities observed.With the balloon shaft locked at the valve alignment position, the balloon shaft was able to be pulled without any slipping observed, meeting specification.Crimp balloon double wall thickness measurements were taken and found to be within specification.A device history records (dhr) review did not reveal any manufacturing issues that could have contributed to the complaint event.Review of history for the related lot revealed no additional similar complaints.A review of complaint history from december 2017 to november 2018 for the edwards commander delivery system (all models and sizes) revealed other similar complaints with returned devices that were confirmed, but no potential manufacturing non-conformances were identified during the investigations.Available information suggested that patient and/or procedural factors may have contributed to the reported events.A review of the complaint history revealed that the occurrence rate did not exceed the november 2018 control limit for the applicable trend categories.The sapien 3 thv system is currently approved in germany for use in aortic position.The available ifu and training materials were reviewed for instructions relevant to the described procedure and no ifu/ training deficiencies were identified.The crimp balloon was 100% inspected, including the distal and proximal inner diameter, wall thickness, and foreign matter, impurities, contamination, fisheyes, and gel spots.During balloon manufacturing, the inflation balloon is inspected.The balloons are 100% inspected for wall thickness and visual defects.Balloons are sampled from the work order for burst testing and additional visual inspection.The laser weld joint is 100% visually inspected for bubbles and to ensure there is a smooth bond joint with no gaps between components.The balloon assembly is 100% visually inspected prior to laser bonding for any contamination.Balloon inspections are also 100% completed during balloon pleat, fold, and forming process.During manufacturing, the commander delivery system was 100% inspected by manufacturing and quality.Devices are 100% leak tested.All manufacturing lots undergo product verification (pv) testing on a sampling plan.During product verification testing, balloon burst pressure testing was performed on a sampling basis, was measured and met the statistical acceptance.Additionally, under pv tensile testing for the related work order, locknut to collet engagement force was tested.The work order was calculated to have met the acceptance criteria.Tensile testing of the inflation balloon to crimp balloon bond was also performed.The work order was calculated to have met the acceptance criteria.The complaints for ¿handle ¿ fine adjust difficulty¿ and ¿balloon - torn¿ were confirmed based upon imagery review and visual inspection of the returned devices.No manufacturing non-conformances were identified and review of available information (complaint history, lot history, and dhr) did not 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.Further, no training/ifu deficiencies were identified.Per device training materials, valve alignment should be done in a straight section of the vasculature.If the physician performs the valve alignment process in a tortuous anatomy, it may result in increased forces being applied and tension on the delivery system as described in the original report.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.The flex tip gouges seen and compression seen are indicative of high alignment forces.In addition, imagery review shows slight curvature at the location of valve alignment.If the thv is unseated during alignment, it can result in higher than usual valve alignment forces and a torn crimp balloon.Per report, valve alignment was performed in the inferior vena cava and severe tension and twisting of the delivery system was observed.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.Although a root cause is unable to be definitively determined, it is likely that procedural factors (performing valve alignment in tortuosity) contributed to the complaint event.Additionally, a capa captures further investigation to address complaints related to crimp balloon tears.The capa identified a potential manufacturing factor which was correlated with an increase in reported complaints.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 ¿handle ¿ fine adjust difficulty¿ and ¿balloon - torn¿ were confirmed.No manufacturing non-conformances were identified in the returned device.Available information suggests that procedural factors (performing valve alignment in tortuosity) may have contributed to the complaint event.Since no product non-conformances or ifu/training inadequacies were identified, and the trend categories does not exceed control limits, no corrective or preventive action is required at this time.Per management discretion, the balloon torn issue and it associated risks have previously been assessed and documented in a product risk assessment (pra).Additionally, for the balloon torn issue, a capa captures further investigation and corrective action related to manufacturing.  although no ifu/training material deficiencies were identified, edwards has decided to proceed with including additional information that currently exists in the training manuals, into this device ifu related to tension build-up in the device.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• 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
• MDR Report Key: 8176104
• MDR Text Key: 131145771
• Report Number: 2015691-2018-05401
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2018

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: 06/26/2020
• Device Model Number: 9610TF29
• Device Lot Number: 61443580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 02/04/2019; 07/23/2020
• Supplement Dates FDA Received: 02/06/2019; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention