It was reported that supera stents were implanted in the right superficial femoral artery without issue.A 7x80mm armada 35 percutaneous transluminal angioplasty (pta) catheter was then advanced with an unspecified 6f sheath to the heavily calcified, mildly tortuous, 95% stenosed, de novo common femoral artery lesion.The balloon ruptured at nominal pressure.The armada pta catheter felt resistance with the sheath during removal, and the balloon separated in the sheath.The sheath, pta catheter, and an unspecified guide wire were removed together.While advancing another unspecified guide wire and sheath, what appeared to be a piece of the balloon was noted to be caught in the supera stent.A non-abbott balloon was inflated and a covered stent were used to embed the separated portion of balloon against the vessel wall.There were no adverse sequelae and no clinically significant delay in the procedure.No additional information was provided.
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Visual analysis was performed on the returned device.The reported balloon rupture and separation were confirmed.The difficulty removing was not tested due to the condition of the 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 incidents and/or complaints reported from this lot.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the balloon rupture was the result of interaction with the heavily calcified 95% stenosed lesion.It is likely that the rupture initiated longitudinal.In addition, the resistance noted during removal and radial separation of the balloon was likely the result of the ruptured balloon material catching on the introducer sheath during removal.The additional medical intervention to embed the separated balloon material was related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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