Medtronic received information that a pflex (4.75 mm x 25 mm) and an unknown pipeline product failed to open during a procedure to address an unruptured fusiform aneurysm located in the internal carotid artery (ica) posterior communicating artery segment.It was confirmed that the pipeline device and its accessories were prepped according to their indications for use (ifu).It was reported that the health care provider (hcp) attempted to open/flower the pipeline device in the m1 segment multiple times, but the device would not open after unsheathing 2/3 of the device; greater than 50% of the device was deployed.The hcp then attempted to position the device in the ica, but it again would not open.The device was removed from the microcatheter and rhv, and it was noted that the proximal end of the device looked crimped; however, only the middle part of the product was placed in a bend.Another device of the same size was used and it also would not open.The same diagnostics/troubleshooting were performed on the replacement device.It was noted, however, that the replacement device appeared normal upon removal and was not crimped.A 4.5 mm x 25 mm pipeline device was then used and opened on the first attempt.It was confirmed that usage of the new size resulted in a good outcome.The patient's vessel tortuosity was noted as severe; however, there was no known impact or consequence to the patient.No further complications were reported/anticipated.
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