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The delivery system was not returned to edwards lifesciences for evaluation as it was discarded by the facility.However, video images of the event were provided for review.The images were reviewed and the following observations were made.The valve was not able to be aligned between the markers.Valve alignment appeared to be performed at a bend, resulting in significant flex shaft compression and valve diving.These observations suggest that there was significant tension in the system.The difficulties encountered during valve alignment are likely due to significant vessel tortuosity, which can be seen in the cine of delivery system advancement.During manufacturing the delivery system undergoes multiple 100% inspections.The delivery systems are inspected for general specifications for s3 balloons, flex tip assembly and bonding, crimp balloon molding process, fine adjust knob and locking collet assembly, crimp balloon to inflation balloon laser bond, spring coil installation, balloon pleat/fold/forming and final inspection.The delivery system then undergoes functional product verification testing and tensile product verification testing.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the reported complaint event.A device history record (dhr) review performed revealed no issues that would have contributed to the complaint events.A lot history review of the lot number was performed and revealed no other complaints relating to ¿delivery system ¿ difficulty with valve alignment¿, ¿balloon ¿ leakage¿, ¿delivery system ¿ withdrawal difficulty ¿ valve, through sheath¿, or ¿handle ¿ fine adjust difficulty¿.A review of the complaint history from (b)(6) 2017 to (b)(6) 2018 revealed other returned complaints for ¿delivery system ¿ difficulty with valve alignment¿, ¿balloon ¿ leakage¿, ¿delivery system ¿ withdrawal difficulty ¿ valve, through sheath and ¿handle ¿ fine adjust difficulty¿.No manufacturing non- conformances were identified.A review of the complaint history revealed that the occurrence rate did not exceed the may control limit for the trend categories of ¿valve alignment difficulties¿ and ¿withdrawal difficulty¿.However, the occurrence rate exceeded the (b)(6) 2018 control limits for the trend categories of ¿leakage¿ and ¿fine adjust difficulty¿.The commander delivery system instructions for use, device preparation manual and procedural training manual were reviewed for instructions/guidance on device preparation/usage.No ifu/training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure modes is not required at this time.The complaints ¿delivery system ¿ difficulty with valve alignment¿ and ¿handle ¿ fine adjust difficulty¿ were able to be confirmed.Due to the unavailability of the device and relevant imagery, ¿balloon ¿ leakage¿ and ¿delivery system ¿ withdrawal difficulty ¿ valve, through sheath¿ were unable to be confirmed.Due to unavailability of device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, the presence of a manufacturing non-conformance was unable to be confirmed.However, a review of complaint history and manufacturing mitigations revealed that it is unlikely a manufacturing issue contributed to the complaint.Additionally, a review of ifu/training manuals revealed no deficiencies.Balloon ¿ leakage since the device was able to be successfully de-aired, it is likely that the leakage source was not present on the device out-of-box and was created during the procedure.The following patient and/or procedural factors can possibly contribute to delivery system leakage: the crimp balloon is torn and separates adjacent to the i/c bond.Potential root causes for the tearing of the crimp balloon material proximal to the i/c bond have previously been identified and documented in a pra.The pra demonstrated that performing valve alignment in tortuous anatomy could lead to valve diving, resulting in increased forces being applied to the bond area and causing weakening/tearing adjacent to the bond area.As noted, the patient¿s vessel was severely tortuous and valve diving was seen during imagery review.Under simulated tortuous conditions, 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.Excessive manipulation of the delivery system during the procedure (e.G.During delivery system insertion/advancement or valve alignment) results in kinking or damage to the balloon shaft or balloon catheter bonds (i.E.Nose tip/inflation balloon, crimp balloon/balloon shaft).Calcification in the patient anatomy damages the inflation balloon and/or crimp balloon.As stated, the access vessel was moderately calcified.It¿s possible that the balloon was damaged by calcification while tracking in the severely tortuous anatomy.Delivery system ¿ difficulty with valve alignment and handle ¿ fine adjust difficulty attempting alignment in tortuous anatomy with the presence of valve diving can lead to high alignment forces and likely contributed to difficulties with alignment and perceived difficulties with fine adjust.As seen in imagery review, valve alignment was performed in a bend and valve diving and flex shaft compression occurred, supporting that there was likely high alignment forces and tension in the delivery system.Delivery system ¿ withdrawal difficulty ¿ valve, through sheath non-coaxial retrieval of the valve in tortuous anatomy and not centering the valve on the flex tip prior to retrieval can cause the valve to get caught on the sheath tip.This can lead to withdrawal difficulties of the valve through the sheath.A definite root cause is unable to be determined at this time, but based on given information, patient/procedural factors may have contributed to the complaint event.No manufacturing or ifu/labeling inadequacies were identified.However, available information suggests that patient/procedural factors, contributed to the reported events.Review of complaint history revealed that the occurrence rate did not exceed the monthly control limit for the trend categories of ¿valve alignment difficulties¿ and ¿withdrawal difficulty¿.However, the occurrence rate did exceed the monthly control limit for the trend categories of ¿leakage¿ and ¿fine adjust difficulty¿.No corrective or preventative action is required.
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Udi (b)(4), additional information indicates the access vessel was severely tortuous, moderately calcified, and had a mld > 10 mm.Doctor believes difficulty with valve alignment and balloon rupture was due to patient vessel tortuosity.Less than 20% of balloon was inflated during de-airing.There was no difficulty advancing delivery system through sheath.There was a lot of tension was experienced and the system was torqued.The balloon ruptured prior to inflation and did not inflate at all.The device was returned fully inserted through an expandable sheath, with the valve crimped on the inflation balloon.The proximal portion of the balloon shaft was bent, likely from return packaging.Review of photographs, videos, or imagery showed the valve was not able to be aligned between the markers.Valve alignment appeared to be performed at a bend, resulting in significant flex shaft compression and valve diving.These observations suggest that there was significant tension in the system.The difficulties encountered during valve alignment are likely due to significant vessel tortuosity, which can be seen in the cine of delivery system advancement.From the provided imagery, the complaints for difficulty with valve alignment and fine adjust, and flex shaft damage can be confirmed.The returned device was visually inspected.The crimp balloon was separated proximal to i/c bond.The valve struts were bent/damaged.There was compression on the flex shaft and gouges on the flex tip.There was a kink on sheath shaft, damage to the sheath distal tip and bunching of sheath liner.Gouges on the flex tip and compression/damage on the flex shaft further support that significant tension was present in the system during valve alignment, resulting in the difficulties with valve alignment and fine adjust.Damage to the valve struts and sheath distal tip confirm that there was difficulty retrieving the delivery system into the sheath.The balloon shaft was able to be locked at the warning marker, and full fine adjust functionality was able to be used, supporting that a device non-conformance did not contribute to issues with valve alignment.The double wall thickness of the crimp balloon proximal to the tear was measured, as an out of specification wall thickness could have contributed to the balloon tear.Measured components were within specifications.Dhr review was performed for the components that are the most relevant to the complaint event.Due to the emerging trend in ic bond complaints, the tubing lots and resin for the crimp balloon underwent further review, and in this case, were not identified as a suspect lot.The work orders above did not reveal any issues that could have contributed to this complaint event.A lot history review of the related work order was performed and revealed no other complaints relating to ¿delivery system ¿ difficulty with valve alignment¿, ¿balloon ¿ torn¿, ¿delivery system ¿ withdrawal difficulty ¿ valve, through sheath¿, ¿handle ¿ fine adjust difficulty¿, or ¿flex shaft ¿ damaged¿.A review of the complaint history from june 2017 to may 2018 revealed other returned complaints for ¿delivery system ¿ difficulty with valve alignment¿ for the commander delivery system (all models and sizes).Thirty two complaints were confirmed, but no manufacturing non-conformities were found in the returned samples.Available information suggests that patient/procedural factors may have contributed to the reported events.Five complaints were unable to be confirmed.No potential manufacturing non- conformance were identified.Patient/procedural factors may have contributed to the reported events.The occurrence rate did not exceed the may control limit for the trend category of ¿valve alignment difficulties¿.A review of the complaint history from june 2017 to may 2018 revealed other returned complaints for ¿balloon ¿ torn¿ for the commander delivery system (all models and sizes).Complaints were confirmed, but no manufacturing nonconformance that would have contributed to the complaints were identified.Available information suggested that the tears may have occurred after valve deployment and were the result of excessive force during withdrawal through the sheath.Due to the high criticality level for this failure mode, a product risk assessment (pra) was previously initiated for risk assessment.Others complaints were also confirmed, but no manufacturing nonconformance that would have contributed to the complaints were identified.Available information suggested that the tears may have occurred during valve alignment and could be attributed to patient/procedural factors.Due to the high criticality level for this failure mode, a product risk assessment (pra) was previously initiated for risk assessment.In addition, to address the emerging trend in ic bond complaints, a capa is being updated.The occurrence rate did not exceed the may control limit for the trend category of ¿damaged¿.A review of the complaint history from june 2017 to may 2018 revealed other returned complaints for ¿delivery system ¿ withdrawal difficulty ¿ valve, through sheath¿¿ for the commander delivery system (all models and sizes).Complaints were confirmed, but no manufacturing nonconformance were identified on the returned devices.Available information suggests procedural and/or patient factors may have contributed to the events.The occurrence rate did not exceed the may control limit for the trend category of ¿withdrawal difficulty¿.A review of the complaint history from june 2017 to may 2018 revealed other returned complaints for ¿handle ¿ fine adjust difficulty¿ for the commander delivery system (all models and sizes).Complaints were unable to be confirmed.No manufacturing non-conformances were identified in the returned device.Available information suggests that patient and/or procedural factors may have contributed to the complaint event.The occurrence rate did exceed the may control limit for the trend category of ¿fine adjust difficulty¿.A review of the complaint history from june 2017 to may 2018 revealed no other returned complaints for ¿flex shaft ¿ damaged¿ for the commander delivery system (all models and sizes).The occurrence rate did not exceed the may control limit for the trend category of ¿damaged¿.Instructions for use (ifu), device preparation manual, procedural training manual were reviewed for instructions/guidance on device preparation/usage.No ifu/training deficiencies were identified.During general specification for s3 balloons, 100% balloon dimensional inspection is performed.Balloons are inspected for working length, balloon diameter, proximal and distal leg id, proximal leg od, double wall thickness.100% balloon visual defects inspection is performed.The balloon is inspected for mechanical damage and deformation.During crimp balloon molding process, 100% balloon dimensional inspection is performed.The balloon distal id, proximal id, and wall thickness are inspected. during balloon visual inspection, balloons are inspected for defects.During flex catheter preparation, flex shaft visual inspection is performed, and accepted if the flex shaft is smooth with no mechanical damage or sharp/rough edges.During fine adjust knob and locking collet assembly, fine adjust knob assembly and final handle assembly is performed.During crimp balloon to inflation balloon laser bond, laser bond visual inspection is performed and laser weld joint is inspected and reject bubbles that cover more than bond area than visual standard or for burns. during balloon pleat, fold, & forming, balloon size commingling & visual inspection and visual balloon inspection is performed.During final inspection, distal to proximal visual inspection and functional inspection is performed.During functional product verification (pv) testing, visual inspection, fine adjustment verification, and bond inspections are performed.During tensile product verification testing, locknut/collet engagement tensile tested are performed as well as inflation balloon/crimp balloon tensile force is tested.All tested sample units from the related lot passed.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the reported complaint event.The complaints ¿delivery system ¿ difficulty with valve alignment¿, ¿balloon ¿ torn¿, ¿delivery system ¿ withdrawal difficulty ¿ valve, through sheath¿, ¿handle ¿ fine adjust difficulty¿, and ¿flex shaft ¿ damaged¿ were confirmed.However, investigation of the device, complaint history, lot history, and dhr revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Regarding balloon ¿ torn, 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 product risk assessment.The physician performed the valve alignment process in a tortuous anatomy (note: the patient access vessel is severely tortuous and there is curvature in the aorta), resulting in increased forces being applied to the crimp balloon.Performing valve alignment at a bend or angle caused 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.When the thv is unseated during alignment, it can result in higher than usual valve alignment forces, which may result in a crimp balloon tear.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. because valve alignment was done in tortuous anatomy and valve diving occurred, higher forces were required to align the valve, leading to increased difficulty during fine adjustment to align the valve.Significant tension in the system during the alignment step due to these factors caused the flex shaft to buckle and become damaged.Non-coaxial retrieval of the valve in tortuous anatomy and not centering the valve on the flex tip prior to retrieval can cause the valve to get caught on the sheath tip.This can lead to withdrawal difficulties of the valve through the sheath.A definite root cause is unable to be determined at this time, but based on given information, patient/procedural factors most likely contributed to the 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. regarding ¿delivery system ¿ difficulty with valve alignment¿, ¿delivery system ¿ withdrawal difficulty ¿ valve, through sheath¿, and ¿flex shaft ¿ damaged¿, since no manufacturing non-conformances, labeling, or ifu/training deficiencies were identified, no corrective and preventative actions are required.Since no product nonconformance was confirmed and the occurrence rate did not exceed the complaint control limits, a product risk assessment is not required.Regarding ¿balloon ¿ torn¿, a capa is being updated to address the recent correlation in balloon tear complaint rates with alternate extrusion processing methods.Per management discretion, due to the high criticality of the failure mode, the balloon torn issue and its associated risks have previously been documented and assessed in a product risk assessment.Although no product nonconformance was confirmed in the returned complaint sample and the occurrence rate did not exceed the control limit, further investigation was performed on the crimp balloon tubing and resin lots.Regarding ¿handle ¿ fine adjust difficulty¿, since no manufacturing non-conformances, labeling, or ifu/training deficiencies were identified, no corrective and preventative actions are required.Although the trend category of ¿fine adjust difficulty¿ exceeded the may 2018 control limit for the commander delivery system, no manufacturing non-conformances were identified and a review of available information identified no product non-conformances or ifu/training manual deficiencies related to this issue.As such, a product risk assessment (pra) escalation is not required.No manufacturing non-conformances or ifu/training manual deficiencies have been identified in the investigations thus far.Regarding ¿balloon ¿ torn¿, the complaint for balloon torn was confirmed.No manufacturing non-conformities were found in the returned sample.Available information suggests that patient factors (high valve alignment forces, tortuous vasculature) may have contributed to the events.Due to the high criticality level for ¿balloon ¿ torn¿, a product risk assessment was previously initiated for risk assessment.In addition, to address the emerging trend in ic bond complaints, a capa is being updated to include the investigation of potential factors that may contribute to reported complaints.Regarding ¿delivery system ¿ difficulty with valve alignment¿, ¿delivery system ¿ withdrawal difficulty ¿ valve, through sheath¿, ¿flex shaft ¿ damaged¿, ¿handle ¿ fine adjust difficulty¿, the complaints were confirmed, but no manufacturing non-conformities were found in the return sample.Available information suggests that patient/procedural factors (tortuous vasculature) may have contributed to the events.No labeling or ifu inadequacies have been identified.Review of complaint history revealed that the occurrence rate exceeded the monthly control limit for the trend category of ¿fine adjust difficulty¿.No corrective or preventative action is required at this time.
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