It was reported that the procedure was to treat a left anterior descending artery.A perforation was caused by another device and 3 graftmaster covered stents were used to treat the perforation.A 3.5 x 19 mm graftmaster stent was advanced to be deployed; however, when inflated, the balloon would not fully inflate and the stent dislodged.The dislodged stent was then crushed against the vessel wall with a balloon catheter.Outside the anatomy, it was noted that there was a pin hole in the shaft near the hub.The perforation was quite large so two stents were required to seal the perforation.First, a 3.5 x 16 mm graftmaster stent was deployed at 20 atmospheres.Then a second 3.5 x 19 mm graftmaster stent was deployed at 22 atmospheres; however, there was also difficulty inflating the balloon.The stent implant was deployed to completely seal the perforation.Outside the anatomy, it was noted that there was a pin hole in the shaft near the hub.The procedure was continued and was completed without issue.The patient was in stable condition.There was no adverse patient sequela reported.No additional information was provided.
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(b)(4).A visual and functional inspection was performed on the returned device.The reported inflation issue and shaft leak were confirmed.It should be noted in the graftmaster rapid exchange (rx), coronary stent graft system, domestic, instructions for use clearly states not to exceed the rbp.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 determined the reported difficulties appear to be 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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