H6 correction: medical device problem code 1494 - incorrect anatomy added.A visual and dimensional inspection was performed on the returned device.The reported stent dislodgement and stretched stent were confirmed.The electronic lot history record (elhr) and corrective and preventive action (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents.It was reported that the procedure was to treat a lesion in the left anterior tibial artery.It should be noted that the xience alpine everolimus eluting coronary stent system (eifu), electronic instructions for use states: the xience alpine stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length = 32 mm) with reference vessel diameters of = 2.25 mm to = 4.25 mm.In addition, the xience alpine stent system is indicated for treating de novo chronic total coronary occlusions.It is unknown if the ifu deviation contributed to the reported event.It was reported that the 3.5x38mm xience alpine stent delivery system (sds) was prepared per instructions for use (ifu) and was advanced to the lesion when it was noted that the stent was not on the balloon.The stent was found inside the protective sheath and was noted to be stretched.It should be noted that the xience alpine everolimus eluting coronary stent system (eifu), electronic instructions for use (ifu) states: prior to using the xience alpine stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.It is unknown if the ifu deviation contributed to the reported event.The investigation determined the reported difficulties appear to be related to the operational context of the procedure, as it is likely that inadvertent mishandling during unpackaging/preparation of the device (sheath/stylet removal) contributed to the reported stretched stent and observed material deformation, ultimately causing the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.
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