The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined that the reported balloon rupture and subsequent resistance removing was likely related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a heavily tortuous, moderately calcified distal right coronary artery (drca) that was 90% stenosed.Once the lesion was pre-dilated a 4.0x12mm xience sierra was advanced and resistance was felt with anatomy.The device was inflated once at 8 atmospheres (atm) when the balloon ruptured, the stent implant was not deployed.Another non-abbott device was used to successfully complete the procedure.There no were no adverse patient effects and no clinically significant delay.No additional information was provided.
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