It was reported that the procedure was performed to treat a lesion in the internal carotid artery with mild calcification and mild tortuosity.An emboshield nav6 embolic protection system (eps) was deployed at the target location.The 7-10x40mm acculink self expanding stent (ses) was advanced to the lesion through a 6f 80cm non-abbott sheath over an unspecified 0.014 guide wire.The stent delivery system handle was pulled all the way, with no resistance noted; however, the acculink stent was only partially deployed at the target site.The non-abbott sheath was raised as much as possible and the acculink delivery catheter was removed, with half of the stent remaining in the guiding catheter.Using the eps retrieval catheter, the stent was pushed from the guiding catheter and was able to be completely deployed partially inside the target lesion and partially in healthy tissue.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
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The device was returned for analysis.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.Electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is likely that interaction with the mildly calcified and mildly tortuous anatomy and/or inadvertent mishandling resulting in the noted device damages (wrinkled sheath, multiple shaft bends) resulted in preventing the shaft lumens from moving freely thus resulting in the reported activation failure.As reported, the non-abbott sheath was raised as much as possible and the acculink delivery catheter was removed, with half of the stent remaining in the guiding catheter.Using the embolic protection system (eps) retrieval catheter, the stent was pushed from the guiding catheter and was able to be completely deployed partially inside the target lesion and partially in healthy tissue.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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