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.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigation's have been established for potential causes.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.Based on the information provided, a definitive cause for the reported material rupture cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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