It was reported that the procedure was to treat a lesion located in the left anterior descending / first diagonal arteries.Reportedly, the nc trek balloon ruptured in the patient causing a proximal dissection of the vessel, requiring the implantation of a second non-abbott stent.Post dilatation was performed with a stent balloon.Kissing balloon was performed at the bifurcation resulting in improvement and timi iii flow.No additional information was provided.
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Visual and functional inspections was performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The reported patient effect of dissection is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use ifu (adverse effects section) as a known patient effect.The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported unexpected medical intervention appears to be related to circumstances of the procedure.A conclusive cause for the reported patient effect of vascular dissection and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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