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PROMUS ELITE Adverse Event — Malfunction (MDR 2134265-2020-04875)

PROMUS ELITE Adverse Event — Malfunction (MDR 2134265-2020-04875) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROMUS ELITE; Generic name: CORONARY DRUG-ELUTING STENT; Manufacturer: BOSTON SCIENTIFIC CORPORATION.

DevicePROMUS ELITE
Generic nameCORONARY DRUG-ELUTING STENT
ManufacturerBOSTON SCIENTIFIC CORPORATION
Report number2134265-2020-04875
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceCOMPANY REPRESENTATIVE, HEALTH
NarrativeDEVICE IS A COMBINATION PRODUCT.
SourceopenFDA MAUDE (device adverse events)

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