Catalog Number 1011344-40 |
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 11/04/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).There was no reported device malfunction, and the product was not returned.A review of the lot history record revealed no non-conformances or exceptions that would have contributed to the reported event.The investigation concluded that a definitive cause for the reported patient effect could not be determined.The reported patient effect of restenosis is a known observed and potential patient effect as listed in the rx acculink domestic, instructions for use.Although a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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It was reported that on (b)(6) 2013 the 7-10x40 rx acculink was implanted in the left internal carotid artery (lica).The patient was re-admitted to the hospital on (b)(6) 2015 with carotid artery disease.Magnetic resonance angiogram (mra) found stenosis in the lica.Carotid angiogram on (b)(6) 2015 found 15% in-stent restenosis in the lica.Treatment was an increase in the daily aspirin dose to 325 mg/day.No additional information.
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Manufacturer Narrative
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(b)(4).The reported patient effects of angina, visual disturbances and arrhythmia are known observed and potential patient effects as listed in the rx acculink domestic instructions for use.
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Event Description
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Subsequent to the previously filed report, additional information was received that the percentage of stenosis in the left internal carotid artery was 75% via the magnetic resonance angiogram, not 15% as previously reported.The patient also had chest pain, dizziness, transient vision loss, substernal pressure and palpitations.The patient was referred to the cardiologist for follow-up.No additional information was provided.
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Search Alerts/Recalls
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