Model Number H7493918420350 |
Device Problems
Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Thrombosis (2100)
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Event Date 02/19/2018 |
Event Type
Death
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Manufacturer Narrative
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Device is combination product.Device evaluated by mfr: the complaint device was not received for analysis.The investigation conclusion was unable to be determined.(b)(4).
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Event Description
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It was reported that the patient died.At an unknown time after a promus element plus stent was implanted the patient died.Cause of death is unknown.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was further reported this is the same case as mdr#2134265-2018-03628.Immediately following a proper stent implantation, after the procedure acute in-stent thrombosis occurred.There had been adequate pharmacological therapy with dual antiplatelet agents and weight-adapted heparin.Despite immediate re-coronary angiography, the patient died.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was further reported that the 90% calcified right coronary artery was pre-dilated twice.12 atmospheres for 16 seconds and 12 atmospheres for 9 seconds.After, the 3.5 x 20mm promus element plus was implanted in the proximal portion of the lesion at 14 atmospheres for 18 seconds, and a 3.0 x 16mm promus element plus was implanted in the distal portion at 15 atmospheres for 16 seconds.The result was noted to be good after implantation.Ten minutes later, the patient felt pain in their chest and became hemodynamically unstable.Resuscitation was administered for 30 minutes without success.An angiogram showed that there was a thrombotic occlusion in the proximal right coronary artery.
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Search Alerts/Recalls
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