CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00153
- Event Type
- Injury
- Date Received
- April 5, 2011
- Date of Event
- February 13, 2010
- Report Date
- March 7, 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
INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED HYPERTENSION, ELEVATED CARDIAC ENZYMES, CHEST PAIN AND A SIDE BRANCH OCCLUSION AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, HYPERLIPIDEMIA AND AN UNKNOWN ALLERGY. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. THE TARGET LESIONS WERE THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE PROXIMAL CIRCUMFLEX (CFX) AND THE FIRST OBTUSE MARGINAL (OM). THE MID LAD WAS DESCRIBED AS 80% STENOSED AND DE NOVO. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 3.0MM X 33MM AND A 3.0MM X 8.0MM CYPHER STENT. THE STENTS WERE POST-DILATED AND THE REPORTED RESIDUAL STENOSIS WAS 0%. THE STENTS WERE NOT OVERLAPPING. THE PROXIMAL LAD WAS DESCRIBED AS 95% STENOSED AND DE NOVO. THE LESION WAS DIRECT STENTED WITH THE IMPLANT OF A 3.50MM X 23MM CYPHER STENT AT 14 ATMS. THE STENT WAS POST-DILATED FOR OPTIMAL EXPANSION AND THE REPORTED RESIDUAL STENOSIS WAS 0%. THE CARDIAC ENZYMES WERE NOTED TO BE SLIGHTLY ELEVATED POST-INDEX PROCEDURE. THE PATIENT WAS NOT DIAGNOSED AS HAVING HAD A MYOCARDIAL INFARCTION. DURING THE INDEX PROCEDURE NITROGLYCERIN WAS GIVEN FOR HYPERTENSION AND CHEST PAIN. THE PROXIMAL CFX AND THE OM WERE TREATED FOUR DAYS LATER IN A STAGED PROCEDURE. THE PROXIMAL CFX WAS DESCRIBED AS DE NOVO AND 70% STENOSED. THE LESION WAS DIRECT STENTED WITH A 3.0MM X 13MM CYPHER STENT AT 14 ATMS. THE STENT WAS POST-DILATED FOR OPTIMAL EXPANSION AND THE REPORTED RESIDUAL STENOSIS WAS 10%. THE OM WAS DESCRIBED AS THE LESION BEING IN THE MID SECTION, DE NOVO AND 80% STENOSED. THE LESION WAS DIRECT STENTED WITH A 2.5MM X 28MM CYPHER STENT AT 15 ATMS. THE STENTS WERE POST-DILATED FOR OPTIMAL EXPANSION. OF NOTE THE CARDIAC ENZYMES WERE ALSO NOTED TO BE ELEVATED AFTER THE STAGED PROCEDURE AND PER MEDICAL PERSONNEL THIS WAS DUE TO A SMALL SIDE BRANCH OCCLUSION. THE EVENT WAS NOT TREATED AND THE PATIENT WAS DISCHARGED THE NEXT DAY. APPROXIMATELY FOUR MONTHS POST-PROCEDURE THE PATIENT RETURNED WITH ANGINA. THE PATIENT WAS FOUND TO HAVE ARTERIAL STENOSIS OF THE PROXIMAL RIGHT CORONARY ARTERY. THE EVENT WAS SEVERE. THE STENOSIS WAS TREATED WITH PTCA AND PLACEMENT OF A PROMUS DRUG ELUTING STENT. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCTS. THE EVENT WAS RESOLVED WITH SEQUEL. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. CHEST PAIN, HYPERTENSION, ELEVATED CARDIAC ENZYMES AND SIDE BRANCH OCCLUSION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THE HYPERTENSION THE PATIENT EXPERIENCED IS MOST LIKELY RELATED TO THE CHEST PAIN, WHICH IS MOST LIKELY RELATED TO THE PROCEDURE. ELEVATED CARDIAC ENZYMES ARE A COMMON RESULT OF IMPLANTING CORONARY ARTERY STENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, WHICH LEADS TO DAMAGED HEART CELLS AND THE RELEASE OF CARDIAC BIOMARKER ENZYMES INTO THE SYSTEMIC BLOODSTREAM. THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT. SIDE BRANCH OCCLUSION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. CORONARY VASCULATURE THAT IS IN A BIFURCATION, TORTUOUS, CALCIFIED AND ANGULATED IS OFTEN A PRECURSOR TO THE INABILITY TO MAINTAIN SIDE BRANCH PATENCY ONCE THE MAIN BRANCH IS STENTED. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE INHERENT RISK OF THE PROCEDURE AS WELL AS VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED OF THE REPORTED EVENTS. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FIVE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2011-00152, 3003742446-2011-00153, 3003742446-2011-00154, 3003742446-2011-00155 AND 3003742446-2011-00156.
AFTER THE PTCA AND DES PLACEMENT, THE CARDIAC ENZYMES BECAME ELEVATED. AN ECG PRIOR TO DISCHARGE REVEALED THE PATIENT'S CARDIAC ENZYMES (CKMB) WERE ELEVATED (11.69 / UNL 9) 6 TO 12 HOURS POST PROCEDURE AND (26.93/ UNL 9) AT DISCHARGE. A STAGED PROCEDURE WAS PERFORMED FOUR DAYS LATER WITH CYPHER STENTS PLACED IN THE PROXIMAL CIRCUMFLEX (CXS13300/ LOT 15068665) AND THE FIRST OBTUSE MARGINAL (CXS28500/ LOT 15079398). THE STENTS WERE PLACED SUCCESSFULLY. AN ADVERSE EVENT WAS REPORTED FOLLOWING THE PROCEDURE. IT WAS FOUND THAT THERE WAS AN INCREASE IN CPK-MB (11.57 / UNL 9) AND TROPONIN AFTER PTCA AND STENT PLACEMENT. IN THE PROGRESS NOTES ON (B)(6) 2010, IT STATES THAT AN INCREASE IN CARDIAC ENZYMES WAS SECONDARY TO A SMALL SIDE BRANCH CLOSURE WITHOUT EVIDENCE OF A STENT THROMBUS. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT. APPROXIMATELY FOUR MONTHS POST-PROCEDURE, THE PATIENT RETURNED WITH ANGINA. THE PATIENT WAS FOUND TO HAVE ARTERIAL STENOSIS OF THE PROXIMAL RIGHT CORONARY ARTERY. THE EVENT WAS SEVERE. THE STENOSIS WAS TREATED WITH PTCA AND PLACEMENT OF A PROMUS DRUG ELUTING STENT. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCTS. THE EVENT WAS RESOLVED WITH SEQUEL. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FIVE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 3003742446-2011-00152, 3003742446-2011-00153, 3003742446-2011-00154, 3003742446-2011-00155 AND 3003742446-2011-00156. CONCOMITANT DEVICES: 6FR. CORDIS XBLAD3.5 GUIDECATHETER, 6FR PINNACLE SHEATH, 3.0X15 MAVERICK BALLOON, 2.0X15 APEX BALLOON (BSC), 3.5X15 MAVERICK BALLOON.
INFORMATION RECEIVED FROM THE (B)(4) DATABASE INDICATED THAT THE PATIENT SUFFERED ELEVATED CARDIAC ENZYMES AT DISCHARGE OF THE INDEX PROCEDURE AND DURING STENT PLACEMENT AT THE TIME OF THE STAGED PROCEDURE TWO DAYS LATER. THE ELEVATED ENZYMES DO NOT MEET THE CRITERIA (CK-MB>3X THE UNL DURING OR FOLLOWING PCI WITHIN THE SAME ADMISSION) FOR BEING REPORTABLE. DURING THE INDEX PROCEDURE NITROGLYCERIN WAS GIVEN FOR HYPERTENSION AND CHEST PAIN. ALSO, IT WAS NOTED THAT A SIDE BRANCH OCCLUSION OCCURRED WHICH MAY HAVE THE CULPRIT OF THE ELEVATED ENZYMES. THE LOCATION OF THE SIDE BRANCH OCCLUSION IS UNKNOWN. THE PATIENT IS A (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(4) STUDY. THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2010. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE, AND A POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA. THE TARGET LESIONS WERE THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING ARTERY (LAD). ALSO, THE 1ST DIAGONAL BRANCH UNDERWENT BALLOON ANGIOPLASTY TO TREAT AN 80% OCCLUSION. THE LESIONS WERE DE NOVO. THE PROXIMAL LAD HAD A 95% STENOSIS. THE LESION WAS NOT PRE-DILATED. A CYPHER (CXS23350/ LOT 15065409) STENT WAS SUCCESSFULLY PLACED IN THE LESION AT TEN ATMOSPHERES (ATMS). THE STENT WAS POST-DILATED AS STANDARD PROCEDURE. THERE WERE NO COMPLICATIONS AND NO MALFUNCTION WITH THE STENT. A CYPHER (CXS33300/ LOT 15079810) STENT AND A CYPHER (CXS08300/ LOT 15069237) STENT WERE SUCCESSFULLY PLACED IN THE MID LAD. THE STENTS WERE NOT OVERLAPPING IN THE VESSEL. THE STENTS WERE POST-DILATED AS STANDARD PROCEDURE. THERE WERE NO COMPLICATIONS AND NO MALFUNCTION WITH THE STENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO EKG CHANGES DURING THE PROCEDURE.
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 | 15079810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| L| R |