Model Number H7493926232220 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Congestive Heart Failure (1783); Death (1802); Cardiogenic Shock (2262); Respiratory Failure (2484)
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Event Date 01/25/2017 |
Event Type
Death
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Manufacturer Narrative
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Device is a combination product device evaluated by mfr: it is indicated that the device will not be returned for evaluation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The cause of the reported difficulties could not be determined.(b)(4).
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Event Description
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(b)(4) clinical study.Same case as mfr report#: 2134265-2017-02333.It was reported that post a coronary artery drug eluting stenting treatment procedure, the patient expired.The subject was referred for cardiac catheterization and in (b)(6) 2016, the index procedure was performed.Target lesion #1 was located in the proximal lad with 80% stenosis and was 15 mm long with a reference vessel diameter of 2.5 mm.Target lesion #1 was treated with direct placement of a 2.50 x 20 mm study stent and the residual stenosis was 0%.Target lesion #2 was located in the ramus with 70% stenosis and was 28 mm long with a reference vessel diameter of 2.25 mm.Target lesion #2 was treated with direct placement of a 2.25 x 32 mm study stent and the residual stenosis was 10%.The patient was discharged on dual antiplatelet therapy (aspirin and clopidogrel) 7 days later.In (b)(6) 2017, event of death was reported.The patient had acute respiratory failure that led to death.No additional information and source documents are available at this point of time.
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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 per death certificate acute respiratory failure, cardiogenic shock, congestive heart failure and diabetes mellitus were stated as the cause of death.
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Search Alerts/Recalls
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