Catalog Number M0036121040 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Stroke/CVA (1770); Hemorrhage, Subarachnoid (1893); Dysphasia (2195); Ptosis (2620)
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Event Date 08/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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The device remains implanted.
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Event Description
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It was reported that the microcatheter was pushed out of the left ophthalmic internal carotid artery (ica) aneurysm during the delivery of the subject coil resulting in the distal end of the coil becoming stuck between the "intra-aneurysmal coil-ball".The physician was unable to retrieve the coil and the coil was stretched.The physician pulled back the microcatheter with the coil inside, and placed a stent over the stretched portion of the coil at the level of the ica bifurcation, and detached the coil.After extubating the patient post procedure, the patient had aphasia and left ptosis.The magnetic resonance angiogram (mra) showed a left subarachnoid hemorrhage.There was no treatment administered but it was reported that 11 days post procedure adverse events were resolved without sequelae.The physician stated that the adverse events were not related to the "stretching coil" but it was related to the maneuver necessary to deliver other devices.Pre and post procedure the patient's modified rankin scale was measured of 1.
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Manufacturer Narrative
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The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Information available, indicated that the main coil appeared to have gotten entangled with previously placed coils in the aneurysm.The patient complications (hemorrhage, stroke and subsequent neurological deficits) although anticipated in nature, are likely to have occurred, in part as a result of the damage sustained to the subject coil.An assignable cause of operational context has been assigned to this complaint as procedural factors encountered limited the performance of the device contributing to the reported event.
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Event Description
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It was reported that the microcatheter was pushed out of the left ophthalmic internal carotid artery (ica) aneurysm during the delivery of the subject coil resulting in the distal end of the coil becoming stuck between the ¿intra-aneurysmal coil-ball¿.The physician was unable to retrieve the coil and the coil was stretched.The physician pulled back the microcatheter with the coil inside, and placed a stent over the stretched portion of the coil at the level of the ica bifurcation, and detached the coil.After extubating the patient post procedure, the patient had aphasia and left ptosis.The magnetic resonance angiogram (mra) showed a left subarachnoid hemorrhage.There was no treatment administered but it was reported that 11 days post procedure adverse events were resolved without sequelae.The physician stated that the adverse events were not related to the ¿stretching coil¿ but it was related to the maneuver necessary to deliver other devices.Pre and post procedure the patient¿s modified rankin scale was measured of 1.
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Search Alerts/Recalls
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