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.Additionally, there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.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 a heavily calcified, moderately tortuous, 90% stenosed lesion in the mid left anterior descending coronary artery (mlad).A 3.5x08mm xience skypoint drug eluting stent (des) was advanced to the lesion and inflated but the balloon ruptured on the first inflation to 12 atmospheres (atm).The des was removed and a new, same size xience skypoint des was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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