Model Number 10619 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)
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Event Date 11/19/2018 |
Event Type
Death
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Manufacturer Narrative
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Device is combination product.
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Event Description
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It was reported the patient expired.A 2.25 x 20 synergy drug coated stent was implanted to treat a 2.25x16mm target lesion in the left anterior descending artery.Two hours post procedure the patient expired.
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Manufacturer Narrative
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Device is combination product.Correction to implant date - from (b)(6) 2018 has been changed to (b)(6) 2018.
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Event Description
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It was reported the patient expired.A 2.25 x 20 synergy drug coated stent was implanted to treat a 2.25x16mm target lesion in the left anterior descending artery.Two hours post procedure the patient expired.It was further reported the patient was having chest pain on exertion for the last 6 months.On diagnosis the patient was found hypertensive, had lv dysfunction and the ejection fraction was 35-40%.The patient presented to the hospital with severe chest pain.A 2.25 x 20 synergy drug coated stent was implanted to treat a 2.25x16mm target lesion in the left anterior descending artery.The patient was normal post procedure.After one hour, the patient started having breathlessness.An electrocardiogram (ecg) was performed and found normal.The patients symptoms were managed medically.After some time the patient suddenly felt hypotensive followed by cardiac arrest.Cardiopulmonary resuscitation (cpr) was performed but the patient could not be revived.
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Search Alerts/Recalls
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