BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; STENT, CORONARY, DRUG-ELUTING
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Model Number UNK717 |
Device Problem
Occlusion Within Device (1423)
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Patient Problems
Angina (1710); Cardiomyopathy (1764); Chest Pain (1776); Dyspnea (1816); Reocclusion (1985); Dizziness (2194)
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Event Date 07/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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Device is a combination product.Device evaluated by mfr.: the complaint device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
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Event Description
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Same case as mdr id 2134265-2017-05749.(b)(6) clinical study.It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was myocardial infarction (mi) with unstable angina.Prior to procedure, the patient was found to have elevated biomarkers indicative of ischemia and the patient was referred for cardiac catheterization.On the same day, the index procedure and coronary angiography were performed.The target lesion was located in the mid left anterior descending (lad) artery with 95% stenosis and was 10mm long with a reference vessel diameter of 3.0mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 12mm study stent.Following post-dilation, residual stenosis was 0%.On the following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2016, the patient was hospitalized due to dyspnea and dizziness and the patient was referred for angiography.There were multiple proximal to mid lad stents and the patency of the study stent is unknown.Isr was present in mid lad and it was treated with placement of a 2.75 x 20mm promus element plus drug-eluting stent.The most distal lad stent has a discrete 95% stenosis.The patient was considered for surgical intervention coronary artery bypass graft (cabg surgery) but refused to proceed with the surgery.Nineteen days after, the patient was presented due to stable angina and severe ischemic cardiomyopathy.Based on the patient's persistent symptoms, severe cardiomyopathy, and high-grade lad stenosis, the patient was referred for percutaneous coronary intervention (pci).The 95% stenosis in mid lad was treated with pre-dilatation and by a 3.0 x 12mm non-bsc bioabsorbable scaffold system.Following post-dilatation, no residual stenosis and timi 3 flow was noted.The patient was discharged on dual antiplatelet therapy on the same day.
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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 in (b)(6) 2016, the patient was diagnosed with multivessel coronary artery disease with extensive left anterior descending (lad) artery in-stent restenosis including focal area up to 95% in the mid lad.The patient was considered for surgical intervention based on the patient's multivessel coronary artery disease and lvef of approximately 20%.
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Manufacturer Narrative
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Describe event or problem, relevant tests/lab data and patient codes updated.(b)(4).
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Event Description
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It was further reported that following post-dilatation during the index procedure, residual stenosis was 0% with no evidence of dissection, distal embolization, or loss of side branch.In (b)(6) 2016, the patient presented with complaints of progressive exertional dyspnea and dizziness.The patient had ischemic cardiomyopathy and premature coronary artery disease.The patient is also having recurrent vague chest pain and shortness of breath.Subsequently, the patient was recommended for cardiac catheterization to assess for progression of disease or restenosis.
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