Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
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Medtronic received report that the pipeline flex stent was released completely, the marksman microcatheter retrieved the tip of guidewire, the tip of the guide wire was broken, the operator slowly withdrew the microcatheter and the guidewire together, and the stent and guide wire were removed.The pushwire was broken at the distal end.There was no friction or difficulty.No patient injury occurred.The devices were prepared and used per the instructions for use (ifu).This event occurred during the treatment of ophthalmic artery segment, unruptured aneurysm, that was saccular.The max diameter was 15mm and neck was 7mm.The distal landing zone was 3.6mm and the proximal was 4mm.The vessel anatomy was minimal in tortuosity.
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