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As reported by an edwards lifescience affiliate in (b)(4), during a transfemoral tavr, insertion difficulty, alignment difficulty, valve movement on balloon and delivery balloon tear occurred.The patient had a mild tortuosity near the bifurcation of renal arteries and a severe tortuosity in the thoracic descending aorta.While inserting the delivery system, strong resistance was felt.Then valve alignment was performed at the abdominal artery where less tortuosity was seen.Stronger resistance than usual was encountered during gross alignment and the valve less advance on the balloon.The valve finally moved between the markers; but the alignment wheel was turned to the very end and it sounded some strange noise.The physician unlocked the balloon catheter and turned the wheel in clockwise in half.When the flex shaft was retracted after crossing the native valve, the valve moved to the aortic side approximately 3mm long.The same event happened although re-alignment was performed.When negative pressure was applied to the balloon for a troubleshooting, blood was visible in the atrion syringe.The valve/balloon assembly was gently retracted and the system was removed with esheath.The system was visually examined and the balloon confirmed to be torn at the balloon shaft.A second 23mm sapien 3 valve was deployed successfully.
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The device was returned for evaluation.The delivery system was returned unlocked with approximately 25% of the fine adjust used, inserted through the loader cap and sheath with the stopcock attached to the inflation port.The delivery system was visually inspected and the following were observed: crimp balloon tear adjacent to i/c bond, valve on inflation balloon, bunching on distal end of the inflation balloon, severe gouges on flex tip, sheath fully expanded as designed with no liner tear, minor soft tip damage and scratch observed just distal to strain relief.Photographs of the device and patient anatomical imagery were provided for review.One of the photographs showed the delivery system was retrieved with the valve over the inflation balloon.Another photograph reveals that the crimp balloon is torn adjacent to the i/c bond.The patient anatomy images were reviewed and the following observations were noted: calcification observed in left common and external iliacs, calcification observed in right common and external iliacs, and tortuosity observed in the abdominal and descending aorta.Functional testing was performed.The balloon shaft was able to be pulled to the valve alignment marker and locked.Due to the balloon tear, fine adjust was used off the inflation balloon.Full fine adjust could be used with no abnormalities observed.The locknut/collet was engaged and the balloon shaft was pulled to a force of 58.9n with no slippage observed.This met the specification.Dimensional analysis was performed and double wall thickness measurements were taken on the crimp balloon.If the thickness were to deviate from specification, it may make the balloon more susceptible to a tear and may be indicative of a manufacturing nonconformance.The measurements met the double wall thickness specification.A device history review (dhr) was performed and did not reveal any manufacturing related issues that would have contributed to this complaints.Review of history for the lot revealed no additional complaints for ¿balloon ¿ torn,¿ ¿delivery system ¿ difficulty with valve alignment¿, or ¿delivery system ¿ valve movement on balloon¿.A review of complaint data revealed that the complaint rate did not exceed the july 2018 control limits for the applicable complaint trend category (¿damaged¿) (¿valve alignment difficulties¿) and (¿valve movement on balloon¿).No instruction for use (ifu) or training deficiencies were identified.Inspections during the manufacturing process and testing performed during the product verification process make it unlikely that a manufacturing nonconformance contributed to the 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. balloon ¿ torn delivery system ¿ difficulty with valve alignment the complaints for ¿delivery system ¿ difficulty with valve alignment¿ and ¿balloon ¿ torn¿ were confirmed based upon the photograph provided by the field and visual inspection of the returned device.Dimensional testing of the crimp balloon double wall thickness met specification and visual inspection of the device did not reveal a manufacturing nonconformance.Furthermore, review of available information (complaint history, lot history, and dhr) did not identify any evidence of manufacturing nonconformances.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.Per device training materials, valve alignment should be done in a straight section of the vasculature.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.Per the case notes and provided patient information, tortuosity was present in the descending and abdominal aorta, supporting this scenario.It should also be noted that gouges were observed on the flex tip of the returned device, which are indicative of high valve alignment forces and valve diving.Per the complaint description, ¿stronger resistance than usual was encountered during gross alignment and the valve less advance on the balloon,¿ and ¿the alignment wheel was turned to the very end and it sounded some strange noise.¿ the high valve alignment forces likely caused the balloon to tear and may have been the observed strange noise.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.The root cause for the reported complaint events can likely be attributed to patient and/or procedural factors.To address the emerging trend in ic bond complaints, the tubing lots and resin for the crimp balloon underwent further review.Crimp balloon extrusion lot was not found to be correlated with the increasing complaint trends.Delivery system ¿ valve movement on balloon the complaint for ¿delivery system ¿ valve movement on balloon¿ was unable to be confirmed as imagery of the procedure was not provided.It is likely that the balloon tore during valve alignment.Once torn, the balloon can become more compressed distal to the valve, shifting the valve forward relative to the marker bands and making the valve appear to be aligned.However, retracting the flex catheter would have caused the balloon to un-compress and shift the valve proximally.This would give the appearance of the valve moving on the balloon.As a result, the root cause for the reported complaint events can likely be attributed to procedural factors.Balloon ¿ torn the complaint for ¿balloon ¿ torn¿ was confirmed.No manufacturing non-conformances were identified in the returned device.Available information suggests that patient (tortuosity) and/or procedural factors (valve diving) may have contributed to the complaint event.Per management discretion, the balloon torn issue and its associated risks have previously been documented and assessed.In addition, to address the emerging trend in ic bond complaints, the corrective preventative action is being updated.Delivery system ¿ difficulty with valve alignment the complaint for ¿delivery system ¿ difficulty with valve alignment¿ was confirmed.No manufacturing non-conformances were identified in the returned device.Available information suggests that patient (tortuosity) and/or procedural factors (valve diving) may have contributed to the complaint event.Since no product non-conformances or ifu/training inadequacies were identified, and the trend category does not exceed control limits, no corrective or preventive actions are required.Delivery system ¿ valve movement on balloon the complaint for ¿delivery system ¿ valve movement on balloon¿ was confirmed.No manufacturing non-conformances were identified in the returned device.Available information suggests that procedural factors (torn balloon) may have contributed to the complaint event.No product non-conformances or ifu/training inadequacies were identified, and the trend category does not exceed control limits.An investigation was previously initiated per management discretion for product risk assessment and corrective and preventative action was previously initiated to drive further investigation and potential corrective/preventive action(s).
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