CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2010-00292
- Event Type
- Injury
- Date Received
- August 16, 2010
- Date of Event
- February 1, 2010
- Report Date
- February 1, 2011
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
NOTIFICATION WAS RECEIVED FOR THE (B)(4) STUDY INDICATING THAT APPROXIMATELY FOUR MONTHS AFTER INDEX PROCEDURE THE (B)(6) FEMALE HAD ANGINA AND REVASCULARIZATION VIA CABG DUE TO IN-STENT RESTENOSIS IN MULTIPLE AREAS OF THE OF THE 1ST OBTUSE MARGINAL. THE PATIENT HAD NO ANGINA DURING THE 6 MONTHS FOLLOW UP. AT INDEX PROCEDURE A TOTAL OF SEVEN STENTS WERE IMPLANTED IN FOUR LESIONS: TWO OVERLAPPING CYPHER RX STENTS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, TWO OVERLAPPING IN THE MID LAD, ONE CYPHER RX IN THE PROXIMAL CIRCUMFLEX (CX) AND TWO OVERLAPPING CYPHER RX STENTS IN THE 1ST OBTUSE MARGINAL (OM) BRANCH. IT WAS REPORTED THAT THE RESTENOSIS ONLY INVOLVED THE 1ST OM AND THAT THERE WAS NO IN-STENT RESTENOSIS OR RESTENOSIS WITHIN 5MM OF THE OTHER IMPLANTED STENTS. ADDITIONALLY, IT WAS NOTED THAT ELEVATED CARDIAC ENZYMES WERE DOCUMENTED POST INDEX PROCEDURE. IT WAS INDICATED THAT THERE WERE NO DEVICE DELIVERY PERFORMANCE ISSUES AND NO PROCEDURAL COMPLICATIONS RELATED TO THE TREATMENT OF ANY OF THE LESIONS. THE PATIENT HAD NO ANGINA AND WAS DISCHARGED THE FOLLOWING DAY ON CLOPIDOGREL AND ASPIRIN. THE PATIENT'S MEDICAL HISTORY INCLUDED PREVIOUS PCI, HYPERLIPIDEMIA, HYPERTENSION, DIABETES MELLITUS/TYPE II, EPILEPSY, AND FAMILY HISTORY OF CORONARY ARTERY DISEASE. AT INDEX PROCEDURE THE 85% STENOSIS IN THE 1ST OBTUSE MARGINAL BRANCH WAS TREATED WITH IMPLANTATION OF TWO CYPHER STENTS. THE TYPE B2 LESION WAS DE NOVO, WITH MODERATE TORTUOSITY AND IN A BIFURCATION WITH A SIDE BRANCH EQUAL OR MODE THAN 2.5MM. THE RVD WAS 2.0 WITH A LESION LENGTH OF 20MM. THE LESION WAS NOT PRE-DILATED. A 2.5 X 18MM CYPHER RX STENT WAS DEPLOYED AT 11 ATM. THE STENT WAS POST-DILATED WITH A 3.0 X 13MM BALLOON AT 11 ATM. A 2.75 X 23MM CYPHER RX STENT DEPLOYED AT 11 ATM SUCCESSFULLY OVERLAPPING AND DISTAL FROM THE FIRST STENT, AS IT DID NOT FULLY COVER THE TARGET LESION. THE STENT WAS POST-DILATED WITH A 3.0 X 8MM BALLOON AT 16 ATM PER STANDARD PROCEDURE. RESIDUAL STENOSIS WAS 0%. ADDITIONAL TREATMENT INCLUDED A 2.5 X 28MM AND A 2.25 X 23MM CYPHER STENT TO TREAT AN 40MM 80% STENOSED MID LEFT ANTERIOR DESCENDING (LAD), A 2.75 X 33 AND 3.0 X 13MM CYPHER STENT TO TREAT A 35MM 85% STENOSIS OF THE PROXIMAL LAD, AND A 3.0X8MM CYPHER TO TREAT A 15MM LONG 70% STENOSIS OF THE PROXIMAL CIRCUMFLEX (CX). THE INSTRUCTIONS FOR USE OUTLINES TO FULLY COVER THE ENTIRE LESION, ALLOWING FOR ADEQUATE STENT COVERAGE INTO HEALTHY TISSUE PROXIMAL AND DISTAL TO THE LESION. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. THERE WERE NO PRODUCT MALFUNCTION OR ANGIOGRAPHIC COMPLICATIONS AND RESIDUAL STENOSIS OF ALL LESIONS WAS REPORTED AS 0. THE PRODUCT REMAINS IMPLANTED AND IS; THEREFORE, NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15073549 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING THE BLOOD FLOW. THE PATIENT'S EXTENSIVE DISEASE INCLUDING MULTIPLE LONG LESIONS REQUIRING PLACEMENT OF MULTIPLE STENTS IS A LIKELY FACTOR CONTRIBUTING TO THE ELEVATED ENZYMES POST PROCEDURE. PATIENT AND LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION THAT IT IS RELATED TO ANY DEVICE DESIGN, MANUFACTURING OR PERFORMANCE ISSUES. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS AND THROMBOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, AND BIFURCATIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE MULTIPLE PATIENT FACTORS AND VESSEL/LESION CHARACTERISTICS ALONG WITH POSSIBLE PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO INDICATION THAT IT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.
AN 85% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) BRANCH WAS ALSO TREATED. THE TYPE B2 LESION WAS DE NOVO, WITH MODERATE CALCIFICATION AND WITH EQUAL OR MORE THAN 30MM IN LENGTH. THE LESION WAS PRE-DILATED WITH A 3 X 15MM BALLOON AT 10 ATM. A 2.5 X 28MM CYPHER RX STENT WAS DEPLOYED AT 15 ATM SUCCESSFULLY. THE STENT WAS POST-DILATED WITH A 3.0 X 8MM CYPHER STENT AT 17 ATM. A 2.25 X 23MM CYPHER STENT WAS DEPLOYED AT 11 ATM OVERLAPPING AND DISTAL FROM THE FIRST STENT, AS IT DID NOT FULLY COVER THE TARGET LESION. THE STENT WAS POST-DILATED WITH A 3.0 X 12MM CYPHER STENT AT 11 ATM. A 70% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WAS ALSO TREATED. THE TYPE B1 LESION WAS DE NOVO AND 15MM LONG. THE LESION WAS PRE-DILATED WITH A 3.0 X 8MM NON-CORDIS BALLOON AT 20 ATM. A 3.0 X 8MM CYPHER RX STENT WAS DEPLOYED AT 12 ATM SUCCESSFULLY. THE STENT WAS POST-DILATED WITH A 3.0 X 8MM BALLOON AT 14 ATM PER STANDARD PROCEDURE. THERE WAS NO PRODUCT MALFUNCTION OR ANGIOGRAPHIC COMPLICATIONS. AN 85% STENOSIS IN THE 1ST OBTUSE MARGINAL BRANCH WAS ALSO TREATED. THE TYPE B2 LESION WAS DE NOVO, WITH MODERATE TORTUOSITY AND IN A BIFURCATION WITH A SIDE BRANCH EQUAL OR MODE THAN 2.5MM. THE LESION WAS NOT PRE-DILATED. A 2.5 X 18MM CYPHER RX STENT WAS DEPLOYED AT 11 ATM. THE STENT WAS POST-DILATED WITH A 3.0 X 13MM BALLOON AT 11 ATM. A 2.75 X 23MM CYPHER RX STENT DEPLOYED AT 11 ATM SUCCESSFULLY OVERLAPPING AND DISTAL FROM THE FIRST STENT, AS IT DID NOT FULLY COVER THE TARGET LESION. THE STENT WAS POST-DILATED WITH A 3.0 X 8MM CYPHER STENT AT 16 ATM PER STANDARD PROCEDURE. THE PATIENT HAD STABLE ANGINA DURING THE 30 DAYS FOLLOW UP. APPROXIMATELY ONE MONTH AFTER THE INDEX PROCEDURE THE PATIENT HAD AN UNSCHEDULED VISIT FOR UNSTABLE ANGINA. THE PATIENT HAD A STAGED PROCEDURE FOR TREATMENT OF A KNOWN LESION AND ANGINA. THERE WAS NO IN-STENT RESTENOSIS OF A DRUG-ELUTING STENT. THE LESION WAS DE NOVO AND DISTAL IN THE MID LAD AND WAS NOT WITHIN 5MM FROM THE STENTS IMPLANTED IN THIS LESION. AN ENDEAVOR, MEDTRONIC DRUG-ELUTING STENT WAS DEPLOYED AT 15 ATM SUCCESSFULLY. THE STENT WAS POST-DILATED WITH 2.5 X 15MM BALLOON AT 20 ATM. APPROXIMATELY FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH CORONARY ARTERY DISEASE AND RECURRENT IN-STENT RESTENOSIS IN MULTIPLE AREAS OF THE 1ST OBTUSE MARGINAL THAT REQUIRED CORONARY ARTERY BYPASS SURGERY. THE EVENT WAS IN THE TARGET VESSEL, NON-TARGET LESION. THE PATIENT HAD NO ANGINA DURING THE 6 MONTHS FOLLOW UP. CONCOMITANT MEDICAL PRODUCTS: TEGRETOL 400 MG (START DATE: 1978), MYSOLINE 250MG (START DATE: 1975), ISOSORBIDE 30MG (START DATE: 2007), TOPROL XL (START DATE: 2007), NIFEDIPINE ER 60MG (START DATE: 2007), PEPCID 20MG (START DATE: (B)(6) 2010), AMILORIDE/HYDROCHLOROTHIAZIDE 5/50MG (START DATE: 2007), GLYBURIDE 5MG (START DATE: 2001), METFORMIN 250MG (START DATE: 2001), ASPIRIN 325MG (START DATE: 2007) AND AMILORIDE/HYDROCHLOROTHIAZIDE 5/50MG (START DATE: (B)(6) 2010). THE PRODUCT REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF TWO DEVICES IMPLANTED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBER 3003742446-2010-00291 AND 3003742446-2010-00292. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
THIS IS ONE OF SEVEN PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS: 3003742446-2010-00292, 3003742446-2011-00202, 3003742446-2010-00291, 3003742446-2011-00203, 3003742446-2011-00204, 3003742446-2011-00205 AND 3003742446-2011-00206. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
NOTIFICATION WAS RECEIVED FOR THE (B)(4) STUDY INDICATING ELEVATED CARDIAC ENZYMES POST INDEX PROCEDURE IN WHICH SEVEN CYPHER STENTS WERE IMPLANTED TO TREAT FOUR LESIONS. ADDITIONAL INFORMATION RECEIVED VIA THE ADJUDICATION PROCESS INDICATED A PROTOCOL DEFINED NON-Q WAVE MYOCARDIAL INFARCTION (MI) ASSOCIATED WITH THIS EVENT. IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST PROCEDURE, THE PATIENT HAD A STAGED PROCEDURE OF A NONTARGET LESION GREATER THAN 5MM FROM ANY PREVIOUSLY IMPLANTED STENTS WITH NO IN-STENT OR PERI-STENT RESTENOSIS. THE ADJUDICATION PROCESS REPORTED A "DISCRETE IN-STENT RESTENOSIS" WITH 26% INCREASE FROM FINAL INDEX RESIDUAL STENOSIS. NO ADDITIONAL TREATMENT OF THIS STENTED AREA WAS REPORTED. APPROXIMATELY FOUR MONTHS AFTER INDEX PROCEDURE, THE PATIENT HAD ANGINA AND REVASCULARIZATION VIA CABG DUE TO IN-STENT RESTENOSIS IN MULTIPLE AREAS OF THE 1ST OBTUSE MARGINAL. THERE WAS NO IN-STENT RESTENOSIS OR RESTENOSIS WITHIN 5MM OF THE OTHER IMPLANTED STENTS. ADDITIONAL INFORMATION RECEIVED VIA THE ADJUDICATION PROCESS INDICATED A PROTOCOL DEFINED NONQ WAVE MI ASSOCIATED WITH THIS EVENT. THE PATIENT HAD NO ANGINA DURING THE 6 MONTHS FOLLOW UP. AT INDEX PROCEDURE, THE PATIENT WITH A HISTORY OF DYSLIPIDEMIA, HYPERTENSION, DIABETES MELLITUS TYPE II, ONGOING EPILEPSY, PREVIOUS NON-TARGET VESSEL PCI, AND FAMILY HISTORY OF CORONARY ARTERY DISEASE PRESENTED WITH NO ANGINA. A TOTAL OF SEVEN STENTS WERE IMPLANTED IN FOUR LESIONS: TWO OVERLAPPING CYPHER RX STENTS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, TWO OVERLAPPING IN THE MID LAD, ONE CYPHER RX IN THE PROXIMAL CIRCUMFLEX (CX) AND TWO OVERLAPPING CYPHER RX STENTS IN THE 1ST OBTUSE MARGINAL (OM) BRANCH. IT WAS INDICATED THAT THERE WERE NO DEVICE DELIVERY PERFORMANCE ISSUES AND NO PROCEDURAL COMPLICATIONS RELATED TO THE TREATMENT OF ANY OF THE LESIONS. THE PATIENT HAD NO ANGINA AND WAS DISCHARGED THE FOLLOWING DAY ON CLOPIDOGREL AND ASPIRIN. AT INDEX PROCEDURE, THE 85% STENOSIS IN THE 1ST OBTUSE MARGINAL BRANCH WAS TREATED WITH IMPLANTATION OF TWO CYPHER STENTS. THE TYPE B2 LESION WAS DE NOVO, WITH MODERATE TORTUOSITY AND IN A BIFURCATION WITH A SIDE BRANCH EQUAL OR MODE THAN 2.5MM. THE RVD WAS 2.0 WITH A LESION LENGTH OF 20MM. THE LESION WAS NOT PRE-DILATED. A 2.5 X 18MM CYPHER RX STENT WAS DEPLOYED AT 11 ATM. THE STENT WAS POST-DILATED WITH A 3.0 X 13MM BALLOON AT 11 ATM. A 2.75 X 23MM CYPHER RX STENT DEPLOYED AT 11 ATM SUCCESSFULLY OVERLAPPING AND DISTAL FROM THE FIRST STENT, AS IT DID NOT FULLY COVER THE TARGET LESION. THE STENT WAS POST-DILATED WITH A 3.0 X 8MM BALLOON AT 16 ATM PER STANDARD PROCEDURE A 0% RESIDUAL WAS REPORTED BY THE STUDY WITH A 26% FINAL RESIDUAL STENOSIS REPORTED BY THE ANGIOGRAPHIC CORE LAB. ADDITIONAL TREATMENT INCLUDED A 2.5 X 28MM AND A 2.25 X 23MM CYPHER STENT TO TREAT A 40MM 80% STENOSED MID LEFT ANTERIOR DESCENDING (LAD), A 2.75 X 33 AND 3.0 X 13MM CYPHER STENT TO TREAT A 35MM 85% STENOSIS OF THE PROXIMAL LAD, AND A 3.0X8MM CYPHER TO TREAT A 15MM LONG 70% STENOSIS OF THE PROXIMAL CIRCUMFLEX (CX). THE INSTRUCTIONS FOR USE OUTLINES TO FULLY COVER THE ENTIRE LESION, ALLOWING FOR ADEQUATE STENT COVERAGE INTO HEALTHY TISSUE PROXIMAL AND DISTAL TO THE LESION. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. THERE WERE NO PRODUCT MALFUNCTIONS OR ANGIOGRAPHIC COMPLICATIONS. THE RESIDUAL STENOSIS WAS REPORTED AS 0. HOWEVER, ADDITIONAL INFORMATION REPORTED THAT THE ANGIOGRAPHIC CORE LAB REPORTED A 44% FINAL RESIDUAL STENOSIS IN THE MID LAD, 19% IN THE PROXIMAL LAD, AND 10% IN THE PROXIMAL CX. THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15073549 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. POST PROCEDURAL MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AS LISTED IN THE IFU. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING THE BLOOD FLOW. THE PATIENT'S EXTENSIVE DISEASE INCLUDING MULTIPLE LONG LESIONS REQUIRING PLACEMENT OF MULTIPLE STENTS IS A LIKELY FACTOR CONTRIBUTING TO THE ELEVATED ENZYMES POST PROCEDURE ADJUDICATED AS A PROTOCOL-DEFINED MYOCARDIAL INFARCTION. PATIENT AND LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION THAT IT IS RELATED TO ANY DEVICE DESIGN, MANUFACTURING OR PERFORMANCE ISSUES. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. RESTENOSIS WITH RELATED MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS AND THROMBOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, AND BIFURCATIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE MULTIPLE PATIENT FACTORS AND VESSEL/LESION CHARACTERISTICS ALONG WITH POSSIBLE PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. THERE IS NO INDICATION THAT IT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS IS ONE OF SEVEN PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS: 3003742446-2010-00292, 3003742446-2011-00202, 3003742446-2010-00291, 3003742446-2011-00203, 3003742446-2011-00204, 3003742446-2011-00205 AND 3003742446-2011-00206.
THE INFORMATION RECEIVED FROM (B)(4) DATABASE INDICATED THAT APPROXIMATELY FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH CORONARY ARTERY DISEASE AND RECURRENT IN-STENT RESTENOSIS IN MULTIPLE AREAS OF THE 1ST OBTUSE MARGINAL BRANCH THAT REQUIRED CORONARY ARTERY BYPASS SURGERY. THE EVENT WAS IN THE TARGET VESSEL, NON-TARGET LESION. THE PATIENT HAD NO ANGINA DURING THE 6 MONTH FOLLOW UP. FOR THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH AN 85% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE TYPE B1 LESION WAS DE NOVO, WITH MODERATE CALCIFICATION AND WITH EQUAL OR MORE THAN 30MM IN LENGTH. THE LESION WAS PRE-DILATED WITH A 3 X 12MM BALLOON AT 10 ATM WITH A NON-CORDIS BALLOON. A 2.75 X 33 CYPHER RX STENT WAS DEPLOYED AT 15 ATM SUCCESSFULLY. THE STENT WAS POST-DILATED WITH A 3.0 X 33MM AT 16 ATM BALLOON PER STANDARD PROCEDURE. A 3.0 X 13MM CYPHER RX STENT WAS DEPLOYED AT 14 ATM SUCCESSFULLY OVERLAPPING AND DISTAL FROM THE FIRST STENT, AS IT DID NOT FULLY COVER THE TARGET LESION. THIS STENT WAS POST-DILATED WITH A 3.0 X 13MM BALLOON AT 18 ATM. THERE WAS NO PRODUCT MALFUNCTION OR ANGIOGRAPHIC COMPLICATIONS.
THE CLINICAL EVENTS COMMITTEE (CEC) ADJUDICATION INDICATED AGREEMENT WITH "PROTOCOL DEFINED NON-Q WAVE MI (TARGET VESSEL) AND ARC [PERI-PROCEDURAL PCI] WITH EVENT DATE OF (B)(6) 2010 AS RELATED TO PROCEDURE AND RELATED TO DEVICE. BASED ON THIS NEW INFORMATION, A NON Q-WAVE MYOCARDIAL INFARCTION (MI) IS BEING REPORTED FOR ALL STENTS IMPLANTED AT THE INDEX PROCEDURE. THE ADJUDICATION AGREED WITH "PROTOCOL DEFINED NON-Q WAVE MI (TARGET VESSEL) AND ARC [PERI-PROCEDURAL PCI] WITH EVENT DATE OF (B)(6) 2010 AS RELATED TO DEVICE. THE EVENT OF RESTENOSIS ON (B)(6) 2010 WAS PREVIOUSLY CAPTURED FOR THE 2.6X18MM AND 2.75X23MM CYPHER STENTS IMPLANTED IN THE 1ST OBTUSE MARGINAL (OM). BASED ON THE NEW INFORMATION THE EVENT OF NON Q-WAVE MI IS BEING REPORTED FOR THE TWO STENTS IMPLANTED IN THE OM.
ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE EVENT STOP DATE WAS CHANGED TO (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | NA | 15073549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| L| R | PLAVIX| 3.0 X 8MM BALLOON |