(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.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 similar incidents from this lot.The investigation determined the reported failure to advance and difficulty removing the device appear to be related to interactions with the calcification in the anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|
It was reported that the procedure was to treat a lesion located in the mildly calcified, mildly tortuous, 90% stenosed right coronary artery.The 3.5 x 38 mm xience xpedition stent delivery system (sds) failed to cross the lesion.Resistance was also felt during retraction of the sds from the anatomy.Another new 3.5 x 38 mm xience xpedition sds was advanced and implanted.The procedure was successfully completed.The patient outcome was satisfactory.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
|