It was reported that this was a procedure to treat a lesion with heavy calcification and moderate tortuosity in the superior mesenteric artery (sma).The lesion was pre-dilated, and a 4.0 x 38 mm xience sierra stent was implanted successfully.Intravascular ultrasound (ivus) was performed and the stent was well apposed.A 5.0 x 20 mm nc trek balloon catheter was advanced for post dilation.However, at the third inflation at 16 atmospheres the balloon ruptured.During removal of the balloon catheter, the distal shaft separated in two pieces inside the guiding catheter as there was resistance between the devices.A snare device was used to securely with withdrawal the separated distal shaft.The patient remained stable.
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Visual and functional inspections were performed on the returned device.The reported separation was confirmed.The reported balloon rupture was not confirmed; however, the noted tear in the outer member distal to the outer member to hypotube seal is likely what the account perceived as the reported balloon rupture.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device and balloon rupture; however, the reported separation and additional treatment appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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