As reported by an edwards lifesciences affiliate in austria, a 23 mm sapien 3 valve was implanted in the aortic position via transfemoral approach.2-3 seconds post implant the balloon burst.¿the delivery system was tried to pull back, but at the proximal end of the e-sheath no more movement was possible.¿ the devices were unable to be retrieved, therefore surgical intervention was required.The vascular surgeons were unable to remove the device, so part of the vessel had to be cut out and replaced.Upon retrieval of the delivery system, distal tip was observed to be separated and ¿the marker split." the patient was in stable condition post procedure.Photos of the devices after use show the esheath c-marker separated and attached to the balloon, sheath shaft damage and circumferential liner delamination.
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The sheath for this complaint was returned for evaluation.The distal end of the balloon, detached from the rest of the accompanying delivery system, is inserted through the sheath.The loader and inflation device were also returned with the delivery system.Procedural imagery provided shows delamination on the sheath distal end.The delamination is a result of a ruptured delivery system balloon, which broke into two pieces.The sheath has the distal end of the balloon, whereas the proximal end remained attached to the balloon shaft.The sheath appears to be damage on the hdpe and a z-shaped kink can be observed.Per visual inspection, the delamination was confirmed to be circumferential and a different view of the delamination showed that the c-marker band did not detach.Liner bunching was observed.The sheath tubing was twisted and had multiple kinks.A hole or puncture could be seen on the sheath tubing.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.The complaint history has been reviewed and no confirmed manufacturing non-conformances were identified.Due to the nature of the complaint dimensional testing was not required.Due to the condition of the returned device, functional testing was not able to be performed.The ifu, device prepping manual, and procedural training manual were reviewed for instructions or guidance for proper use of the delivery system.The procedural training manual provides additional considerations during delivery system removal delivery system removal: completely unflex the delivery system.Ensure flex tip is still over the triple marker.Ensure balloon lock is locked.Ensure the balloon is completely deflated.Pull the entire delivery system through the sheath.Maintain guidewire position in the aorta.Caution: patient injury could occur if the delivery system is not completely unflexed prior to removal.If delivery system balloon ruptures or leaks during deployment without thv embolization: do not use excessive force.Take care when removing the delivery system through the tip of the sheath.Maintain guidewire position.Check for pv leaks under echo.If post-dilation needed, use a new delivery system.The instructions for use (ifu), device preparation and the training manual were reviewed and no deficiencies were identified.During the manufacturing process, the device was visually inspected and tested several times.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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.The complaints were confirmed based on the condition of the returned device; however, no manufacturing non-conformances were identified during product evaluation.The review of the dhr, lot history, complaint history and manufacturing mitigations further support the notion that a manufacturing non-conformance likely did not contribute to the reported events.A review of the ifu/training materials revealed no deficiencies.The complaint description stated that the delivery system balloon burst during valve deployment.A burst balloon would result in an altered balloon profile that would have made it more likely to get caught on the sheath distal tip during attempted retrieval.Evaluation of the returned sheath showed that the distal end of the burst balloon did indeed become caught on its distal end.If the burst balloon was firmly hooked onto the sheath liner, applying enough force during device withdrawal could have caused the liner to separate, or delaminate, from the shaft tubing.The degree of retrieval force in this case was strong enough to not only delaminate the sheath, but also to cause the delivery system to break into two pieces.The point in which this break occurred at the end of the delaminated region, where additional kinks, deformation, and one puncture to the sheath shaft tubing were observed.It is possible that this retrieval force, which resulted from the profile of the burst balloon, would have also been responsible for this damage.As such, the available information suggests that procedural factors (excessive force during withdrawal of ruptured delivery system balloon) likely contributed to the complaint events.No evidence of a product non-conformance or labeling/ifu inadequacies were identified in the evaluation.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, no product risk assessment, or corrective or preventative actions are required.
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