Model Number H7493911412270 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Anemia (1706); Cardiomyopathy (1764); Congestive Heart Failure (1783); Death (1802); Respiratory Failure (2484)
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Event Date 06/14/2017 |
Event Type
Death
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Manufacturer Narrative
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Device is a combination product.Device evaluated by mfr: the device was not returned for evaluation.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specifications.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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Promus element plus study.It was reported that acute respiratory failure occurred and the patient died.In (b)(4) 2012, the index procedure was performed.The target lesion was a de novo lesion located in the mid left anterior descending artery (lad) with 90% stenosis and was 5 mm long with a reference vessel diameter of 2.75 mm.The target lesion was treated with pre-dilatation and placement of a 2.75 mm x 12 mm study stent and residual stenosis was 0 %.Two days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2017 the subject presented to the hospital due to acute respiratory failure and was hospitalized on the same day.Nine days later, the subject was discharged from the hospital and died the same day.
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Manufacturer Narrative
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Death date corrected from 23-jun-2017 to 24-jun-2017.Describe event or problem and patient codes updated.(b)(4).
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Event Description
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It was further reported that the cause of death was unknown.In (b)(6) 2017, the subject was admitted with the diagnosis of acute encephalopathy with delirium, acute respiratory failure with hypercapnia, dementia, congestive heart failure, compensated chronic unstable anemia, chronic kidney disease and cardiomyopathy.The subject was initiated with breathing medications.One day later, at 0240 hours, the subject was found unresponsive with no pulse.Cardiopulmonary resuscitation was given, however the subject was unresponsive and at 0259 hours the subject was pronounced dead.It is unknown if autopsy was performed.
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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 suspected cause of death was copd and acute respiratory failure and a history of moderate-severe aortic stenosis and history of mild cardiomyopathy contributed to the subject's death.
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Search Alerts/Recalls
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