The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to remove.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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It was reported that the procedure was performed to treat a 95% stenosed, mildly tortuous, and mildly calcified de novo lesion in the left circumflex artery.A 4.0x15mm xience prime stent delivery system (sds) was advanced without issues and the stent deployed at the target expansion pressure.An attempt to remove the sds was made; however, resistance was felt with the guiding catheter.The sds had to be removed as a unit with all the guiding catheter.The procedure was successfully completed with another 4.0x15mm xience prime stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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