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It is to be noted that medwatch form (mw5072810) was received 11/09/2017.The device was returned and a pinhole on the returned crimp balloon was observed 11/28/2017 making the event reportable.The delivery system, sheath, and atrion inflation device were returned after being used in the procedure.The valve was returned crimped on the inflation balloon.The delivery system was returned locked, not fully pulled to the valve alignment marker, and with approximately 1.25¿ of fine adjust used.Atrion inflation device was returned filled with 35ml of clear fluid.The delivery system was visually inspected and the following were observed: valve was returned crimped on the inflation balloon not fully aligned to the distal alignment marker.Pinhole observed on crimp balloon distal to crimp marker.Minor gouges on the flex tip and minor compression on the flex shaft.Functional testing was performed and the delivery system was able to be pulled to the valve alignment marker and locked with the valve still crimped onto the balloon.Full fine adjust and flex were able to be used without any slippage or observed abnormalities.The valve was successfully deployed off the balloon.The device met the locknut/collet engagement force design specification.Dimensional analysis of the crimp balloon was performed.Crimp balloon double wall thickness measurements were taken to ensure that the wall thickness of the material was within specification as a thin wall could contribute to the observed pinhole.The crimp balloon double wall thickness measurements met the specification.A device history review (dhr) was performed on the relevant work orders and did not reveal any issues that could have contributed to the complaint event.A review of history for the lot revealed no other similar complaints for complaint codes ¿delivery system ¿ difficulty with valve alignment ¿ unable¿, ¿handle ¿ fine adjust difficulty¿, and ¿balloon ¿ leakage¿.A review of complaint history reveals that the occurrence rate does not exceed the (b)(4) 2017 control limits for the trend category ¿valve alignment difficulties¿ or ¿leakage¿.The occurrence rate exceeded the (b)(4) 2017 control limits for the trend category, ¿fine adjust difficulty¿.However, no product non-conformances or labelling deficiencies were identified.Therefore, no corrective/preventative actions are required.Based on the review of the instructions for use (ifu) and training manual, no deficiencies were identified.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The complaints for ¿delivery system ¿ difficulty with valve alignment ¿ unable¿ and ¿handle ¿ fine adjust difficulty¿ were unable to be confirmed.A review of ifu/training materials revealed no deficiencies.No manufacturing non-conformances were identified in the returned sample.Furthermore, review of dhr, lot history, manufacturing mitigations, and complaint history did not provide any indication that a manufacturing non-conformance could have contributed to the complaint.During functional testing of the returned device, gross valve alignment and use of fine adjust (with the returned valve) were performed with no abnormalities.Additionally, the device met specification for locknut/collet engagement force.Thus, patient or procedural factors likely contributed to the reported difficulty in valve alignment and use of the fine adjust function.If tension builds in the delivery system prior to and/or during valve alignment, the forces required to pull to align the valve and perform fine adjustment can increase.It was reported that a potential cause of the complaint was that the ¿balloon shaft y connector was rotated clockwise twice and then valve alignment was attempted¿.Documents instruct to pull straight back on the y-connector until the warning marker is visible without bending or applying torque to the proximal end of the balloon catheter.Torqueing or manipulation of the system can lead to an increase of tension in the system, ultimately increasing forces needed to complete valve alignment.Additionally, the patient¿s vessels were mildly tortuous, which could lead to added tension in the system.Performing valve alignment at a bend or angle (such as in a non-straight section of the aorta) 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.Minor gouges on the flex tip observed on the returned device is indicative of this diving.If the thv is unseated during alignment, it can result in higher than usual valve alignment forces, and can create tension in the system in order to achieve final alignment position.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.In addition, residual volume left in the balloon may also contribute to increased forces during valve alignment.This was recreated in a previously performed engineering study as well.Additional patient/procedural factors can also result in difficulty with valve alignment.A potential issue is improper crimping of the valve onto the balloon.The valve may not be crimped to the appropriate size or may have been damaged during the crimping process, which can cause difficulty in downstream actions including valve alignment.The device was evaluated on the back table after the procedure, and it was reported that the ¿valve was able to be moved toward the distal marker outside the esheath and the body¿.Since valve alignment was able to be achieved outside the patient, the root cause can likely be attributed to patient and/or procedural factors.However, a definitive root cause was unable to be determined at this time.The complaint for ¿balloon ¿ leakage¿ was confirmed based on visual inspection of the returned device.A review of ifu/training materials revealed no deficiencies.No manufacturing non-conformances were identified in the returned sample.Furthermore, a review of complaint history, lot history, manufacturing mitigations, and the dhr revealed no indication that a manufacturing non-conformance contributed to the event.As the delivery system was able to be de-aired during device preparation with no note of balloon leakage, it is likely that the damage to the balloon occurred during the procedure.Performing valve alignment at a bend or angle (due to the patient aortic tortuosity) can cause non-coaxiality of the valve in relation to the flex tip thereby damaging the balloon during valve alignment.It is likely that that the reported difficulty with valve alignment (multiple gross valve alignment attempts) led to the pinhole on the crimp balloon.However, the following patient/procedural factors could also have resulted in damage to the balloon: residual fluid in the balloon, which can enlarge the balloon profile and create interference with the valve during valve alignment.Improper crimping of the valve on the balloon.The valve may not be crimped to the appropriate size or may have been damaged during the crimping process.Available information therefore suggests patient factors (tortuosity) and/or procedural factors (valve alignment in a non-straight section) may have contributed to the reported event.However, a definitive root cause was unable to be determined at this time.Delivery system ¿ difficulty with valve alignment ¿ unable.The complaint for ¿delivery system ¿ difficulty with valve alignment ¿ unable¿ was unable to be confirmed and no manufacturing non-conformances were found in the returned sample.Available information suggests patient and/or procedural factors may have contributed to the reported event.No labeling or ifu/training inadequacies were identified.Review of complaint history revealed that the occurrence rate did not exceed the (b)(4) 2017 control limits for this trend category.Therefore, no corrective/preventative actions are required.Handle ¿ fine adjust difficulty.The complaint for ¿handle ¿ fine adjust difficulty¿ was unable to be confirmed and no manufacturing non-conformances were found in the returned sample.Available information suggests patient and/or procedural factors may have contributed to the reported event.Review of complaint history revealed that the occurrence rate exceeded the (b)(4) 2017 control limits for the trend category ¿fine adjust difficulty¿, but no product non-conformances or labelling deficiencies were identified.Therefore, no corrective/preventative actions are required.Balloon ¿ leakage.The complaint for ¿balloon ¿ leakage¿ was confirmed based on visual inspection, but no manufacturing non-conformances were found in the returned sample.Available information suggests patient factors (tortuosity) and/or procedural factors (valve alignment in a non-straight section) may have contributed to the reported event.No labeling or ifu/training inadequacies were identified.Review of complaint history revealed that the occurrence rate did not exceed the (b)(4) 2017 control limits for this trend category.Therefore, no corrective/preventative actions are required.
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As reported by a field clinical specialist regarding a 29 sapien 3 valve in the aortic position via tf approach, while the commander delivery system was in the descending aorta, the operator attempted to align the valve on the balloon with the initial step of pulling back on the balloon shaft, to initially advance it toward the distal marker.Upon doing so, the operator encountered extreme resistance and buckling of the delivery system near the distal point of the pusher.The operator had to pull ¿aggressively¿ with multiple attempts.An attempt was made to move the pusher away from the valve and then advanced it against the valve to try again.The system was pulled back enough to get to the white marker band but the system would not further advance.The flex wheel was not turned.The delivery system was locked and the operator tried to turn the fine adjustment wheel with no success in advancing the valve.The commander delivery system and valve were retrieved through the esheath as one unit.A second esheath, commander delivery system, and valve was used to complete the procedure without issue.After further discussion with the operator, it is believed that with the first delivery system, the balloon shaft y connector was rotated clockwise twice and then valve alignment was attempted and is believe that that amount of torque could have caused increased difficulty in completing the valve alignment properly.The calcification was mild and the tortuosity was mild and did not contribute to the difficulty in alignment.It is to be noted that the commander delivery the delivery system was 'played with' on the back table after it was removed from the patient.The valve was able to be moved toward the distal marker outside the esheath and the body.The commander delivery system is currently not in the position that it was in when the difficulties were encountered.The commander delivery system was evaluated by the hospital's risk management and then was returned to edwards for evaluation.The device was returned for evaluation and a pinhole was observed on the crimp balloon.
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