PATIENT ADMITTED WITH CHEST PAIN 4 DAYS AFTER HIS 4TH PROSORBA TREATMENT. HE WAS DIAGNOSED WITH A BLOCKAGE IN THE LEFT MAIN CORONARY ARTERY DURING CARDIAC CATHETERIZATION IN 2006. ANOTHER CARDIAC CATH WAS PERFORMED FIVE DAYS LATER AND A STENT WAS PLACED. AFTER THIS SECOND CATHETERIZATION, THE PATIENT DEVELOPED RENAL ABNORMALITIES THOUGHT TO BE DUE TO CONTRAST MEDIA LIKELY DUE TO RADIOCONTRAST USED FOR THE CATHETERIZATIONS. MEDICAL HISTORY INCLUDES CORONARY ARTERY DISEASE WITH STENT PLACEMENT IN 2000, OBESITY, IMMOBILITY (MUST USE WALKER), HISTORY OF SMOKING, IDDM AND INTERMITTENT CHEST PAIN WHICH USUALLY SIBSIDES WITH NTG. SYMPTOMS RESOLVED AND PATIENT WAS DISCHARGED. PATIENT RESUMED PROSORBA TREATMENTS THE FOLLOWING MONTH AND HAS HAD NO RECURRENCE OF SYMPTOMS.
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Patient 1
THIS INVESTIGATION IS A CLINICAL INVESTIGATION ONLY. RETURN OF PRODUCT NOT REQUESTED AS EVALUATION OF DEVICE AFTER USE NOT RELEVANT TO REPORTED EVENT. THE DEVICE WAS USED ACCORDING TO LABELED INDICATIONS AND IN THE APPROPRIATE ENVIRONMENT. TEMPORAL RELATIONSHIP OF THE EVENT AND PROSORBA MIGHT SUGGEST A CONTRIBUTORY RELATIONSHIP HOWEVER THIS PATIENT'S CHEST PAIN WAS LIKELY RELATED TO HIS UNDERLYING CARDIAC CONDITION.