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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported material rupture, however, factors that may contribute to material ruptures include, but are not limited to, material damage, interactions with other devices or interaction with lesion calcification and tortuosity.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat the mildly tortuous, moderately calcified right coronary artery with 80% stenosis.The 2.25x23 mm xience skypoint stent delivery system (sds) was advanced to the lesion with no resistance noted.Upon inflation it was noted that the balloon of the sds had ruptured; however, the stent was able to be successfully deployed at the intended site.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
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