Description of Event or Problem · 1
SAME CASE AS MDR 6000093-2005-00478, MDR 6000089-2005-00623, 00624, AND 00626. THE INDEX PROCEDURE CONSISTED OF 5 TARGET LESIONS. TARGET LESION 1 IS A 3 MM VESSEL DIAMETER, 80% STENOSED REGION OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN TREATED THIS LESION BY DIRECT STENTING WITH ONE TAXUS EXPRESS2 8.8% 3.0X16 MM (LOT 7051940) DRUG ELUTING STENT. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. TARGET LESION 2 IS A 2.5 MM VESSEL DIAMETER, 90% STENOSED BIFURCATED REGION OF THE 1ST OBTUSE MARGINAL ARTERY (OM). TARGET LESION 3 IS A 2.5 MM VESSEL DIAMETER, 100% STENOSED BIFURCATED REGION OF THE 2ND OM ARTERY. TARGET LESION 3 BIFURCATED OFF OF TARGET LESION 2. TARGET LESIONS 2 AND 3 WERE BOTH WIRED AND ANGIOPLASTY WAS INITIALLY PERFORMED ON THE 2ND OM ARTERY. ANGIOPLASTY WAS THEN ATTEMPTED ON THE 1ST OM ARTERY BUT THE BALLOON WOULD NOT PASS, PRESUMABLY, AT LEAST IN PART, DUE TO WRAPPING OF THE WIRES. THE WIRE WAS THEN WITHDRAWN FROM THE 2ND OM ARTERY, RESULTING IN ABRUPT CLOSURE AND DISSECTION OF THE 2ND OM ARTERY AT THE TARGET LESION. TARGET LESION 2 HAD A THROMBUS PRESENT BEFORE TREATMENT. THE PHYSICIAN PREDILATED THIS LESION PRIOR TO SUCCESSFULLY PLACING ONE TAXUS EXPRESS2 8.8% 2.5X24 MM (LOT 7243061) DRUG ELUTING STENT. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. TARGET LESION 3 WAS PREDILATED. THE PHYSICIAN TREATED THIS TARGET LESION BY SUCCESSFULLY PLACING ONE TAXUS EXPRESS2 8.8% 2.5X24 MM (LOT 7219143) DRUG ELUTING STENT. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. TARGET LESION 4 IS A 3 MM VESSEL DIAMETER, 70% STENOSED REGION OF THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN TREATED THIS TARGET LESION BY DIRECT STENTING WITH ONE TAXUS EXPRESS2 8.8% 3X16 MM (LOT 7051940) DRUG ELUTING STENT. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. TARGET LESION 5 IS A 2.5 MM VESSEL DIAMETER, 80% STENOSED REGION OF THE DISTAL RCA. THE TARGET LESION WAS PREDILATED. THE PHYSICIAN TREATED THE TARGET LESION BY SUCCESSFULLY PLACING ONE TAXUS EXPRESS2 8.8% 2.5X16 MM (LOT 7178034) DRUG ELUTING STENT. THE SITE REPORTED THAT THIS PT EXPERIENCED A NON Q-WAVE MI 1 DAY POST INDEX PROCEDURE. IT WAS REPORTED THAT NO ACTION WAS TAKEN AND THE MI WAS RESOLVED UPON DISCHARGE FROM THE HOSP 1 DAY LATER.