Description of Event or Problem · 1
THE REPORT IS FROM THE STUDY. THE PATIENT WAS A MALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, SMOKING, DIABETES, MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, AND CEREBROVASCULAR DISEASE. THE INDICATION FOR THE INDEX PROCEDURE WAS AN ACUTE MYOCARDIAL INFARCTION GREATER THAN 72 HOURS PRIOR TO THE PROCEDURE. THE FIRST TARGET LESION WAS THE MID LAD. VESSEL DIAMETER WAS 2.25MM AND THE LESION LENGTH WAS 15MM. PRE-PROCEDURE STENOSIS WAS 95%. POST-PROCEDURE STENOSIS WAS 0%. THE LESION WAS DE NOVO, IRREGULAR CONTOUR, AND A TYPE C CLASSIFICATION. THE LESION WAS PRE-DILATED WITH A 2 X 20MM BALLOON AT 14ATM. A CYPHER WAS DEPLOYED AT 18ATM. THE 2ND TARGET LESION WAS THE PROXIMAL LAD. VESSEL DIAMETER WAS 2.75MM AND THE LESION LENGTH WAS 15MM. PRE-PROCEDURE STENOSIS WAS 90%, POST-PROCEDURE STENOSIS WAS 0%. THE LESION WAS DE NOVO, IRREGULAR CONTOUR AND A TYPE C CLASSIFICATION. THE LESION WAS NOT PRE-DILATED. A CYPHER WAS DEPLOYED AT 20ATM AND POST-DILATED BECAUSE THE STENT WAS NOT FULLY EXPANDED. A CYPHER WAS DEPLOYED AT 18ATM TO TREAT A TYPE A DISSECTION WHICH WAS NOTICED AFTER THE FIRST STENT WAS IMPLANTED. THE CYPHER WAS POST-DILATED BECAUSE IT WAS NOT FULLY EXPANDED. THE 3RD TARGET LESION WAS THE FIRST OBTUSE MARGINAL. VESSEL DIAMETER WAS 2.5MM AND THE LESION LENGTH WAS 19MM. PRE-PROCEDURE STENOSIS WAS 90%, POST-PROCEDURE STENOSIS WAS 0%. THE LESION WAS DE NOVO, IRREGULAR CONTOUR AND TYPE B2 CLASSIFICATION. THE LESION WAS NOT PRE-DILATED. A CYPHER WAS DEPLOYED IN THE LESION AT 18ATM. THE PATIENT WAS DISCHARGED 3 WEEKS POST-PROCEDURE. THIS PRODUCT, NOTED IN D4, IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THE STERILE LOT NUMBER FOR THE PRODUCT IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONDUCTED. DISSECTIONS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY STENTS. THE IFU CAUTIONS NOT TO INFLATE THE STENT DELIVERY BALLOON ABOVE RATE BURST PRESSURE OF 16ATMS AS THIS MAY LEAD TO BALLOON RUPTURE OR POSSIBLE DISSECTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT THE PATIENT'S EXTENSIVE MEDICAL HISTORY AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.