(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Udi#: in the absence of a reported part number, the udi cannot be calculated.Failure to follow steps/instructions.The device was not returned for analysis.It should be noted the xience sierra everolimus eluting coronary stent system instructions for use, states: deflate the balloon by pulling negative pressure on the inflation device.Confirm balloon deflation under fluoroscopy and wait 10 to 15 seconds longer.If during withdrawal of the catheter resistance is encountered, re-inflate the balloon up to nominal pressure and repeat the deflation steps to improve balloon rewrap.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot number was not provided.The investigation was unable to determine a conclusive cause for the reported balloon fold issue thus resulting in the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience sierra device referenced is being filed under separate medwatch report.
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It was reported that after implantation of the 3.5 and 4.0 sierra stents, negative pressure was held from 3-5 seconds to deflate the balloons.The balloons of the stent delivery systems (sds) were completely deflated; however, the balloons were noted to be flat.Strong resistance was met during retraction of both the sds through the guiding catheter.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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