It was reported that the procedure was performed to treat a lesion in the right coronary artery (rca).The 5.0x28mm xience skypoint stent delivery system (sds) was advanced and the stent was deployed without issue.After deployment, the sds balloon only partially deflated.During removal, resistance was met; therefore, the sds was removed with the guide liner and guidewire as a unit.Another guide liner and guide wire were used to complete the procedure.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
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The device was returned for analysis.The reported deflation problem could not be confirmed due to the condition the device was returned for analysis.The reported difficulty to remove (guide wire and guiding catheter) were confirmed through obeservations.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 deflation problem; however, factors that could contribute to a deflation problem (slow) include, but are not limited to, the inflation medium being too viscous, buildup of procedural contaminants in the inflation lumen, and/or the users deflation technique.The reported difficult to remove appears to be related to the operational context of the procedure as it is likely the inflated device interacted with the guidewire and/or guiding catheter during removal resulting in the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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