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EXPRESS 2 MONORAIL FOR DISTAL RIGHT CORONARY ARTERY Adverse Event — Injury (MDR MW5005589)

EXPRESS 2 MONORAIL FOR DISTAL RIGHT CORONARY ARTERY Adverse Event — Injury (MDR MW5005589) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EXPRESS 2 MONORAIL FOR DISTAL RIGHT CORONARY ARTERY; Generic name: NONE; Manufacturer: BOSTON SCIENTIFIC.

DeviceEXPRESS 2 MONORAIL FOR DISTAL RIGHT CORONARY ARTERY
Generic nameNONE
ManufacturerBOSTON SCIENTIFIC
Report numberMW5005589
Event typeInjury
Product problemN
Date received2008-02-15
NarrativeBOSTON SCIENTIFIC EXPRESS 2 MONORAIL STENT USED CAUSED A LIFE THREATENING SITUATION WHICH NOW REQUIRES CONTINUED MEDICAL CARE AND DEATH EVENTUALLY. A CARDIAC CATH DONE, FOLLOWED BY OPEN HEART SURGERY, WITH MITRAL VALVE REPLACEMENT WITH A MECHANICAL PROSTHESIS,AND NOW A PACEMAKER WITH A DEFIBRILLATOR. KIDNEY FAILURE IS NOW PRESENT. THERE NEEDS TO BE A RECALL ON THIS PRODUCT OR ELSE MORE PEOPLE WILL
SourceopenFDA MAUDE (device adverse events)

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