H6 updated: the device was returned to edwards lifesciences for evaluation.The 16f esheath plus was returned with 16f dilator returned separately, sheath shaft and dilator have curvature, sheath expanded as designed, sheath distal tip tear along radial score line, deep scratch near distal tip, distal tip torn material attached to ldpe, vertical score line visible on torn material the returned devices were visually inspected, and the following was observed: curvature was noted on the sheath and introducer, sheath liner expanded as designed, sheath distal tip tear along radial score line, distal tip did not open along axial score line, torn distal tip still attached, deep scratches observed near distal tip on hdpe, all score lines were present on distal tip.Due to condition of the returned devices (distal tip torn), no applicable functional testing nor dimensional testing was able to be performed.Imaging evaluation was performed and the following observations were made; tortuous access vessels observed within patient anatomy and calcification noted in patient access vessels.All inspections are conducted on 100% of the units.Per procedure, the sheath shaft components and the esheath final assemblies are 100% visually inspected for defects.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections and tests during the manufacturing process support that it is unlikely that a nonconformance contributed to the reported complaint.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history revealed no other similar returned complaints for the trend categories.The following instructions were reviewed; instruction for ifu for esheath+ introducer set ifu, ifu for commander delivery system, preparation training manual and procedural training manual and no ifu/training deficiencies were identified.A review of the risk management documentation was performed, and 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 complaint failure sheath distal tip torn was confirmed and an existing technical summary captures the root cause analysis.Review of the dhr and lot history did not provide any indication that a manufacturing nonconformance would have contributed to the complaints.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were observed on the device during device preparation.A complaint history review for withdraw sheath from access site difficulty removing sheath revealed no confirmed complaints.Review of the dhr and lot history did not provide any indication that a manufacturing nonconformance would have contributed to the complaints.This event reports a sheath distal tip tear after removal from the patient that has not resulted in a patient harm, or a device failure to perform its function.Also, there was no evidence of product nonconformances or labeling/ifu inadequacies identified in the evaluation.Therefore, it is not included in the risk management file.Edwards continues to monitor complaint history on a monthly basis.Therefore, the review of risk management file is complete, and no further action is required.This event reports difficulty during sheath removal from the patient that has not resulted in a patient harm, or a device failure to perform its function.Also, there was no evidence of product nonconformances or labeling/ifu inadequacies identified in the evaluation.Therefore, it is not included in the risk management file.Edwards continues to monitor complaint history on a monthly basis.Therefore, the review of risk management file is complete, and no further action is required.The complaints for failure sheath distal tip torn and withdraw sheath from access site difficulty removing sheath were confirmed per evaluation of the returned device.However, no manufacturing nonconformance was identified during evaluation.Review of the dhr and lot history did not provide any indication that a manufacturing nonconformance would have contributed to the complaints.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.Per the complaint description, after successful implant of the valve, the clear tip of the esheath+ appeared to be torn when removed from the body.Visual exam of the sheath had the appearance all of the tip was still attached to the sheath.Angiographic examination of the insertion site revealed no apparent vessel injury (right common femoral artery).The operator said he felt slight resistance when the sheath was being removed from the artery.He stated he was not sure if the tip of the sheath was caught by the perclose proglide suture that was placed prior to sheath insertion.Per evaluation of the returned device, the sheath distal tip was observed to be torn radially along the distal edge of the liner.The failure mode is characteristic of sheath tip tear events as described in an existing product risk assessment.While a definitive root cause was unable to be determined, previous investigation indicated that the tear is attributed to improper tip expansion, resulting in interference between the valve and sheath tip.As such, it is possible that improper tip expansion contributed to the distal tip tear.Additionally, 3mensio imagery was also provided and shows the presence of access vessel tortuosity and calcification near the aortic bifurcation.Per the ifu, use caution in tortuous or calcified vessels that would prevent safe entry of the introducer set.Tortuosity can lead to noncoaxial alignment between the crimped valve and the sheath, while calcification can create a constrained condition at the distal tip, which may lead to an increased potential for the valve struts to catch onto the sheath distal tip and tear it.As such, the failure mode may be related to improper expansion of the sheath tip during thv advancement and/or patient factors (tortuosity/calcification) may have contributed to the complaint event.However, a definitive root cause was unable to be determined at this time.As calcification and tortuosity were observed in the patients access vessel, it is possible that it contributed to reported sheath withdrawal difficulty.Tortuosity can subject the sheath to suboptimal angles while calcification can lead to increased friction.Deep scratches were on the sheath shaft, which can be indicative of contact with sharp calcified nodules.As such, patient factors (tortuosity/calcification) may have contributed to the complaint event.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No ifu/labeling/training manual inadequacies were identified.A product risk assessment (pra) was previously initiated to investigate the cause and assess the risks associated with distal tip torn.To address the issue, a corrective action preventative action (capa) was initiated to drive corrective actions.
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