Catalog Number M003124FPP0 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stenosis (2263)
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Event Date 06/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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This is 2 of the 2 reports.The device remains in patient.
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Event Description
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It was reported that approximately 7 months after the procedure for the aneurysm at the left internal carotid, intima hyperplasia was noticed within the flow diverter.It led to a considerable narrowing of the lumen and a reduction of the flow.Therefore, a dsa (digital subtraction angiography) "in stent flow diverter pta (transluminal angioplasty)" was carried out 3 days later.Then the event was resolved without sequelae and the patient was discharged from hospital 4 days after the surgery.In the physician¿s opinion, the event was unrelated to the procedure, the implanted flow diverter or the delivery system.No further information is available for now.
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Manufacturer Narrative
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Executive summary: updated (based on additional information received on 20-feb-2019 that the site updated the relationship from unrelated to related for the implanted flow diverter.).
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Event Description
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It was reported that approximately 7 months after the procedure for the aneurysm at the left internal carotid, intima hyperplasia was noticed within the flow diverter.It led to a considerable narrowing of the lumen and a reduction of the flow.Therefore, a dsa (digital subtraction angiography) "in stent flow diverter pta (transluminal angioplasty)" was carried out 3 days later.Then the event was resolved without sequelae and the patient was discharged from hospital 4 days after the surgery.In the physician¿s opinion, the event was unrelated to the procedure and the delivery system but related to the implanted flow diverter.
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Manufacturer Narrative
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A review of the device history record could not be performed because the lot number was not reported.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.The reported stenosis is a known risk associated with endovascular procedures and is listed as such in the device directions for use.Therefore, an assignable cause of known inherent risk of device has been assigned to the reported event.
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Event Description
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It was reported that approximately 7 months after the procedure for the aneurysm at the left internal carotid, intima hyperplasia was noticed within the flow diverter.It led to a considerable narrowing of the lumen and a reduction of the flow.Therefore, a dsa (digital subtraction angiography) "in stent flow diverter pta (transluminal angioplasty)" was carried out 3 days later.Then the event was resolved without sequelae and the patient was discharged from hospital 4 days after the surgery.In the physician¿s opinion, the event was unrelated to the procedure, the implanted flow diverter or the delivery system.No further information is available for now.
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Search Alerts/Recalls
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