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Model Number M0031681890 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Hemorrhage, Cerebral (1889); Perforation (2001)
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Event Date 05/18/2017 |
Event Type
Death
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Manufacturer Narrative
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This is report 3 of 5 filed for this event.The device is not available to the manufacturer.
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Event Description
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The patient underwent a coil embolization procedure for an un-ruptured aneurysm at junction of internal carotid artery (ica) and ophthalmic artery (opha).Four coils were deployed and a stent was deployed at the neck of the aneurysm because the coil protruded and migrated into the parent vessel.The physician was not able to identify which one of the four coils protruded and migrated, but all four coils deployed with no issues.The stent was deployed to seat against the vessel wall; however, the distal end of the stent did not expand completely.During advancement of a microcatheter (subject device) and guidewire to expand the distal end of the stent, a hemorrhage occurred between the distal of the stent and ic-top.The physician attempted to stop the bleeding with a balloon and neutralize the effect of the heparin, but the bleeding did not stop and a craniotomy procedure was performed.In the physician¿s opinion, the hemorrhage may have been caused by a perforation of the vessel either by the stent, guidewire or microcatheter; however, he was not sure about which device.It was reported that the patient passed away due to the hemorrhage approximately 14 days post the index procedure.No further information is available.
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Manufacturer Narrative
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Manufacturing date ¿ added.Expiration date - added.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The device was confirmed to be in good condition prior to use.However, vessel perforation, death and hemorrhagic events are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
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Event Description
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The patient underwent a coil embolization procedure for an un-ruptured aneurysm at junction of internal carotid artery (ica) and ophthalmic artery (opha).Four coils were deployed and a stent was deployed at the neck of the aneurysm because the coil protruded and migrated into the parent vessel.The physician was not able to identify which one of the four coils protruded and migrated, but all four coils deployed with no issues.The stent was deployed to seat against the vessel wall; however, the distal end of the stent did not expand completely.During advancement of a microcatheter (subject device) and guidewire to expand the distal end of the stent, a hemorrhage occurred between the distal of the stent and ic-top.The physician attempted to stop the bleeding with a balloon and neutralize the effect of the heparin, but the bleeding did not stop and a craniotomy procedure was performed.In the physician¿s opinion, the hemorrhage may have been caused by a perforation of the vessel either by the stent, guidewire or microcatheter; however, he was not sure about which device.It was reported that the patient passed away due to the hemorrhage approximately 14 days post the index procedure.No further information is available.
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Search Alerts/Recalls
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