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EXPRESS2 CORONARY STENT DELIVERY SYSTEM Adverse Event — Injury (MDR 2134265-2008-00457)

EXPRESS2 CORONARY STENT DELIVERY SYSTEM Adverse Event — Injury (MDR 2134265-2008-00457) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EXPRESS2 CORONARY STENT DELIVERY SYSTEM; Generic name: MAF - STENT, CORONARY; Manufacturer: BOSTON SCIENTIFIC CORPORATION.

DeviceEXPRESS2 CORONARY STENT DELIVERY SYSTEM
Generic nameMAF - STENT, CORONARY
ManufacturerBOSTON SCIENTIFIC CORPORATION
Report number2134265-2008-00457
Event typeInjury
Product problemY
Date received2008-02-19
Report sourceForeign, Study, Health Professional, User facility
NarrativeCLINICAL TRIAL. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING PROCEDURE THE STENT EMBOLIZED AND WAS DEPLOYED AT AN UNINTENDED SITE. THE TARGET LESION WAS IN THE 2.7X12MM, MODERATELY TORTUOUS, 55% STENOSED PROXIMAL RCA. THE SITE REPORTED THAT THE 2.75X16MM EXPRESS2 BARE METAL STENT CAME OFF OF THE DELIVERY SYSTEM WHILE ATTEMPTING TO PASS THROUGH PREVIOUSLY PLACED STENTS. THE STENT WAS CRUS
SourceopenFDA MAUDE (device adverse events)

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