As reported by a field clinical specialist, a patient underwent a transfemoral tavr procedure with a 26mm sapien 3 ultra valve in aortic position.During the procedure, upon initial sheath insertion, there was notable difficulty advancing the sheath into the femoral artery.The sheath was removed, and the distal tip was noted to be slightly "cracked" and malformed.A new sheath was prepped and inserted without difficulty.Upon removal after the tavr implant, it was noted that the perclose sutures had failed, leading to the need for inserting a new 14fr sheath (non-edwards product) and a vascular surgery consult.The patient was taken to the or for surgical vascular repair.Of note, the implanting physician stated, "i think the first sheath got caught up on the perclose suture, which is why we had trouble inserting it initially.".
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A supplemental mdr is being submitted due to engineering evaluation findings.The device was not returned to edwards lifesciences for evaluation.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 this event is not required at this time.The complaints for "inability to introduce sheath," "distal tip damage," and "interventional device interacts with non-edwards device" were unable to be confirmed without the return of the device/relevant imagery.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.Inability to introduce sheath & distal tip damage: as reported, "upon initial sheath insertion, there was notable difficulty advancing the sheath into the femoral artery.The sheath was removed, and the distal tip was noted to be slightly "cracked" and malformed." per the training manual, "push force can vary due to angle of access and insertion, vessel diameter, tortuosity and degree of calcification." per imagery review, calcification and tortuosity were present in the patient-s right access vessel.Calcification can create a restricted access and obstacles for insertion, which may lead to the reported resistance during the insertion of the sheath.Tortuosity and calcification can subject the sheath to suboptimal angles, which can also contribute to resistance.Sharp nodules of calcification can damage the sheath tip through direct contact during sheath insertion into the vessel.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.Interventional device interacts with non-edwards device: as reported, "it was noted that the implanting physician stated, 'i think the first sheath got caught up on the perclose suture, which is why we had trouble inserting it initially.'" as calcification and tortuosity were present within the access vessels, it is possible that the sheath interfered with the closure device.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.
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