(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
(b)(4).
The customer reported the device was discarded.
Investigation is not yet complete.
A follow-up report will be submitted with all additional relevant information.
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It was reported that the procedure was to treat the mid common carotid artery that did not have any tortuosity.
A 190 cm emboshield nav6 embolic protection device (epd) was positioned, and pre-dilatation was performed with a 3.
0 x 20 mm nc trek balloon catheter.
A non-abbott stent was then implanted, and post-dilatation was performed with a 5.
0 x 20 mm viatrac balloon catheter.
A neurological test was done, and it was noted that the stent was occluded with thrombus or soft plaque, and there was an issue with the non-abbott stent reducing flow.
The epd had captured embolis and was blocked.
Therefore, the epd was aspirated and removed.
The non-abbott stent was still reducing flow.
A 30 x 9-7 mm xact stent was then implanted inside the non-abbott stent for support, and standard post-dilatation was performed with a 4.
0 x 20 mm viatrac balloon catheter.
Another neurological test was done and the occlusion was still noted.
It was not possible to aspirate as the occlusion was too distal; therefore, the patient was sent to the intensive care unit (icu) and anticoagulation was performed.
No additional information was provided.
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