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EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM Adverse Event — Death (MDR 2134265-2008-00471)

EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM Adverse Event — Death (MDR 2134265-2008-00471) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM; Generic name: MAF STENT, CORONARY; Manufacturer: BOSTON SCIENTIFIC CORPORATION.

DeviceEXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM
Generic nameMAF STENT, CORONARY
ManufacturerBOSTON SCIENTIFIC CORPORATION
Report number2134265-2008-00471
Event typeDeath
Product problemN
Date received2008-02-19
Report sourceForeign, Study, Health Professional, User facility
NarrativeCLINICAL TRIAL. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT DIED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 66.6% STENOSIS, A LENGTH OF 26 MM AND A REFERENCE VESSEL DIAMETER OF 2.8 MM. THE PHYSICIAN PRE-DILATED THE LESION AND PLACED A 3.0 X 32 MM EXPRESS2 BARE METAL STENT. PROCEDURAL SUCCESS WAS OBTAINED WITH LESS THAN 30% RESIDUAL STENOSIS. THE PT W
SourceopenFDA MAUDE (device adverse events)

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