Model Number 10600 |
Device Problem
Failure to Advance (2524)
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Patient Problems
Death (1802); No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)
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Event Date 08/21/2020 |
Event Type
Death
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Event Description
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It was reported that the patient died.The target lesion was located in the left anterior descending (lad) artery.Following pre-dilatation with a 3.00 x 12 apex balloon, a 3.00 x 8mm synergy ii drug-eluting stent was advanced but failed to cross the lesion and the lad went down.The patient was sent to operating room for surgery but before they could get the patient on bypass, he expired.
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Manufacturer Narrative
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This event is a duplicate and has already been reported under emdr 2134265-2020-11969.
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Event Description
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It was reported that the patient died.The target lesion was located in the left anterior descending (lad) artery.Following pre-dilatation with a 3.00 x 12 apex balloon, a 3.00 x 8mm synergy ii drug-eluting stent was advanced but failed to cross the lesion and the lad went down.The patient was sent to operating room for surgery but before they could get the patient on bypass, he expired.
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Search Alerts/Recalls
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