It was reported that the procedure was to treat a moderately calcified distal superficial femoral artery/ proximal popliteal artery that was 75% restenosed.Pre-dilatation was performed with a balloon.A 5x60mm supera stent was deployed as normal.However, under fluoroscopy it was noted that there was no stent implant in the location.When the delivery system was being withdrawn, there was some resistance met with the sheath.Via fluoroscopy it was confirmed that the stent was caught in the sheath.The guide wire was maneuvered through the undeployed stent that was in the sheath, and the sheath was exchanged in order to remove the stent from the patient.Another supera was used to successfully complete the procedure.A clinically significant delay was reported.No additional information was provided.
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The device was returned for analysis.The reported activation failure including expansion failures was unable to be replicated in a testing environment due to the condition of the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that that the distal sheath of the delivery system was entrapped/bent and/or interaction with the moderately calcified and 75% restenosed anatomy resulted in the ratchet being unable to properly engage and release the stent from the delivery system; thus resulting in reported activation failure/ deployment failure.Manipulation of the device likely during removal resulted in the noted device damages (multiple pinched sheath, kinked sheath, tip/jacket separations).The treatment appears to be related to the operational context of the procedure as the guide wire was maneuvered through the undeployed stent that was in the sheath, and the sheath was exchanged in order to remove the stent from the patient.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.Na.
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