Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage, Subarachnoid (1893); Visual Impairment (2138); Thromboembolism (2654)
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Event Date 12/04/2015 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned for analysis as it was implanted in the patient.Attempts were made to obtain additional information, however, our attempts were unsuccessful.The device performed as intended as indicated by successful deployment of the device in the intended located.Thromboembolism, vision deficient, and hemorrhage are known inherent risk of endovascular procedure and is documented in our device¿s instruction for use.The thrombus was treated with eptifibatide which resolved the event.The cause of the local thrombus formation cannot be reliably determined; however, per the reported information, review of ifu, and review of literature to investigate the complaint, the most likely cause for the complaint is the patient condition.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Citation: pipeline embolization device for small paraophthalmic artery aneurysms with an emphasis on the anatomical relationship of ophthalmic artery origin and aneurysm.Griessenauer cj1, ogilvy cs1, foreman pm2, chua mh3, harrigan mr2, stapleton cj4, patel ab4,he l5, fusco mr5, mocco j6, winkler pa7, patel as1, thomas aj1.J neurosurg.2016 dec;125(6):1352-1359.Epub 2016 mar 4.Medtronic received report of 3 symptomatic thromboembolic complication.One patient experienced thrombosis of the left a1 segment of the anterior cerebral artery during the procedure.This was treated with eptifibatide with successful recanalization of the occluded segment.However, postprocedural imaging revealed subarachnoid hemorrhage (sah).At the last follow-up, the patient had no focal neurological deficits.There was report of 2 permanent visual deficits; these patients underwent a formal neuro-ophthalmological evaluation and did not require intervention.
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Search Alerts/Recalls
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