(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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It was reported that during a procedure of the heavily tortuous, mildly calcified, mid right coronary artery (rca), the 3.0 x 38 mm xience xpedition balloon was inflated to 18 atmosphere (atm) but ruptured during deployment and the partially expanded stent was not implanted.The stent was removed on the delivery system without reported issue and a second device was used to successfully complete the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
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(b)(4).Evaluation summary: the device was returned for analysis.The stent implant was stationary on the tightly folded balloon between the markers.There were stretched distal struts on the first two rings on the stent implant.There was no other damage noted to the stent implant.The stent implant was not loose as reported.The reported unstable stent, failure to deploy and material rupture were unable to be confirmed.Based on a visual, dimensional and functional inspection of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the information provided, the reported difficulties were unable to be confirmed; however, the noted damages appear to be related to circumstances of the procedure and not a product quality issue with respect to manufacture, design or labeling.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 other similar incidents from this lot.Based on the information reviewed, there is no evidence to indicate the presence a potential quality issue with respect to manufacture, design or labeling.
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