MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Ischemia (1942); Paresis (1998); Dysphasia (2195)
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Event Date 05/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Miyachi, s., ohnishi, h., hiramatsu, r., yagi, r., kuroiwa, t.(2018).Tied pipeline: a case of rare complication.Neurologia medico-chirurgica, 58(5), 219-224.Doi: 10.2176/nmc.Cr.2017-0151.The pipeline flex devices have not been returned for evaluation.The reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic literature review found a report of complications during or after a pipeline procedure.The patient presented with total abducens nerve palsy on the left side without impairment of visual acuity or field.Imaging revealed a giant aneurysm without identifiable neck at the left cavernous internal carotid artery (ica) and a tandem aneurysm on the near proximal side.The size of distal aneurysm was 28.8 × 19.8 mm, and the proximal one was 10.9 × 8.8 mm.In the distal giant aneurysm, the parent artery lost its course, and the orifice of the distal ica was located in a different direction three-dimensionally, with a twisted relationship from the entry of ica.Flow diversion treatment of the aneurysms was planned.During the procedure, the article states that it was difficult to advance a marksman micro-catheter even using various shaped micro-guidewires; another manufacturer's microcatheter and guidewire was advanced instead after assembling triple loops within the aneurysm.The microcatheter was then exchanged for a marksman.A stent was placed to anchor the distal end of the marksman at the m2; the physician attempted to correct the loops by pulling back the catheter.However, the tip of the microcatheter tended to fall down because the loops interfered with each other.The catheter course was corrected and afterward a ped 3.5 × 35 mm was deployed, then a ped 3.75 × 35 mm was partially deployed.The article states that the marksman again tended to "fall", so the second ped was deployed by unsheathing.There was reportedly difficulty manipulating the marksman due to the multiple loops in the aneurysm; ultimately, the catheter accidentally fell out from the proximal end of the ped losing access to connect subsequent pipeline devices.Multiple attempts to insert the marksman into the free end of the ped were unsuccessful.Finally, the marksman was successfully reinserted into the previously placed ped with the assistance of a balloon catheter, making two intra-aneurysmal turns.A third ped (4.25 x 35 mm) was attempted to be deployed, but the marksman was found to form a knot binding the proximal end of the second ped.The "physician were" unable to detangle the marksman from the ped; the marksman was withdrawn together with the tangled second ped and partially opened third ped.The system (guide catheter, sheath, etc) was removed from the patient.One ped remained in the patient; its proximal end was free in the aneurysmal sac.Postoperatively, the patient presented mild aphasia and right hemiparesis due to scattered ischemic lesions at left cerebral hemisphere due to showered small clots.The patient reportedly improved within three days.One week later, the patient underwent a second procedure in which four additional pipeline devices were placed to cover the neck of both aneurysms.The patient reportedly did not develop any new neurological symptoms immediately post-procedure.One month later, the patient's hemiparesis and aphasia recovered.At the six-month follow-up, angiogram showed complete occlusion of the aneurysm and remodeling pathway formed with telescoping peds.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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