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Catalog Number UNKCASHMERE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Nerve Damage (1979)
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Event Date 08/03/2010 |
Event Type
Injury
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Event Description
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As reported via the (b)(4) study ((b)(6)) a patient experienced left cranial nerve palsy (3rd nerve plasy) after 8 cerecyte coils (4 presidio, 3 helipaq, and 1 cashmere) were implanted.Prior to the index procedure, the patient had presented with a large unruptured, asymptomatic aneurysm of the basilar tip with mrs of 0.An adjunctive stent was placed in the artery prior to coil treatment of the regular shaped aneurysm (15 mm high; 15 mm wide with 10 mm neck).Following coiling, residual filling of the neck was observed by angiographic assessment.No events were reported during the procedure.Patient developed l cranial nerve palsy (3rd nerve palsy) post procedure due to the size and location of the aneurysm.At the time of discharge, palsy continued to persist.The patient was discharged 2 days after the index procedure with mrs 3.The investigator indicated the palsy was moderate and related to the procedure.At the time of the 1-month follow-up mrs had dropped to 2.A ct scan showed ¿post interventional changes following stent assisted coiling of basilar apex aneurysm.These findings are unchanged from 6/10/10.No acute intracranial findings¿.The patient was advised to see an ophthalmologist.At the time of the 6-month follow-up visit, the subject¿s mrs was 0, so the palsy had apparently resolved.
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Manufacturer Narrative
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(b)(6).Complaint conclusion: since the coils were implanted, they were not available for analysis.In addition, the lot number was not provided; therefore, a review of the manufacturing documentation could not be provided.Neurological deficit is a known potential adverse event for intracranial coils and is listed in the instructions for use (ifu) as such.The root cause of the event cannot be confirmed.Based on the information provided, there were no product malfunctions or procedural events related to the coils, therefore, no corrective actions will be taken at this time.This mdr is being submitted as part of a retrospective review as the result of a recent fda audit and with accordance to the requirements of code of federal regulations - 21 cfr part 803, medical device reporting.
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Search Alerts/Recalls
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