CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00024
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 7, 2010
- Report Date
- July 27, 2011
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THIS DEVICE IS ONE OF FOUR PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 3003742446-2010-00429, 3003742446-2010-00430, 3003742446-2010-00443, AND 3003742446-2011-00024. THE (B)(4) STUDY CEC MINUTES FROM THE 7/13/11 MEETING, RECEIVED ON 7/27/2011 WERE REVIEWED, THE ADJUDICATION STATUS-FINAL REPORT. THE COMMITTEE AGREES WITH THE ASSESSMENT OF ARC (PERI-PROCEDURAL), WHICH IS CONSISTENT WITH THE ELEVATED ENZYMES POST-PROCEDURE, THIS EVENT WILL BE CAPTURED AS AN MI AND REPORTED ACCORDINGLY ON ALL THE STENTS. THE COMMITTEE ALSO AGREES WITH ARC (PERI-PROCEDURAL) AND TARGET VESSEL-PERCUTANEOUS INTERVENTION-CLINICALLY DRIVEN, THESE EVENTS HAVE ALREADY BEEN CAPTURED AND REPORTED. INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY THAT POST INDEX PROCEDURE, THE PATIENT SUFFERED AND MI AND THEN 20 MONTHS POST IMPLANTATION OF THREE UNKNOWN CYPHER STENTS TO TREAT TANDEM LESIONS IN A SAPHENOUS VEIN GRAFT (SVG) - DIAGONAL A RESTENOSIS OF ONE OF THE STENTS (CXS13275 LOT 13345377) IN THE MID PORTION WAS TREATED WITH ANOTHER A CUTTING BALLOON AND IMPLANTATION OF ANOTHER CYPHER STENT (CXS 18300 LOT 15052825). POST TREATMENT OF THE RESTENOSIS, THE PATIENT HAD ELEVATED ENZYMES AND CK-MB WAS 3 TIMES THE UPPER NORMAL LIMIT. TEN MONTHS LATER, THE PATIENT RETURNED WITH A MYOCARDIAL INFARCTION. ONE OF THE PREVIOUSLY IMPLANTED CYPHER STENTS HAD RESTENOSIS. IT WAS INDICATED THAT THE RESTENOSED PORTION WAS PROBABLY WITHIN 5MM OF ALL OF THE IMPLANTED CYPHER STENTS. IN ADDITION THERE WAS NEW LESION FORMATION IN THE SVG ANASTOMOSIS TO THE FIRST OBTUSE MARGINAL BRANCH. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY. PRIOR TO STUDY ENROLLMENT, THE (B)(6) FEMALE HAD A HISTORY OF ANGINA WITHOUT POSITIVE FUNCTION STUDY FOR ISCHEMIA WITHIN THE PAST SIX WEEKS. SHE HAD A MEDICAL HISTORY OF FOUR PREVIOUS PCIS, AND CABG, HYPERLIPIDEMIA, AND MYOCARDIAL INFARCTION; THE LATEST WAS A YEAR AND A HALF PREVIOUS TO INDEX PROCEDURE. ASPIRIN AND CLOPIDOGREL WERE ADMINISTERED PRE-PROCEDURE AND POST PROCEDURE. AT INDEX PROCEDURE OF THE INITIAL RESTENOSIS, THE DIAMETER STENOSIS WAS 90% AND REFERENCE VESSEL DIAMETER WAS 3MM WITH A LESION LENGTH OF 15MM WITHOUT HEAVY CALCIFICATION. PREDILATION WAS PERFORMED WITH A 2.5X10 NON CORDIS BALLOON. THE 3.0X13MM CYPHER STENT WAS IMPLANTED AT 20 ATM WHICH IS ABOVE THE RATED BURST PRESSURE OUTLINED IN THE INSTRUCTIONS FOR USE. THERE WERE NO ASSOCIATED ADVERSE EVENTS, PRODUCT DELIVERY DIFFICULTIES OR MALFUNCTIONS. THE RESIDUAL STENOSIS WAS 0% WITH TIMI III. PEAK CK-MB WAS 14 (UPPER LIMIT 3.2NG/ML) AND TROPONIN I 2.4 (UPPER LIMIT 0.4NG/ML). THIS EVENT OF ELEVATED ENZYMES WAS DIAGNOSED AS AN MI. THE PATIENT WAS DISCHARGED ON THE THIRD DAY POST PROCEDURE. AT 30 DAY AND 60 DAY FOLLOW-UP, THERE WAS NO ANGINA OR ADVERSE EVENTS WITHOUT INTERRUPTION OF ANTIPLATELET THERAPY. AT THE 12 MONTH FOLLOW-UP, THE PATIENT REPORTED HAVING ANGINA. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE INITIAL TREATMENT OF THE SVG-DIAGONAL OR THE RESTENOSIS POST STUDY INDEX PROCEDURE. AT THE 15 MONTH FOLLOW-UP, THE PATIENT REPORTED HAVING ANGINA. THE STENTS REMAIN IMPLANTED AND THEREFORE ARE NOT AVAILABLE FOR ANALYSIS. (B)(4): THE LOT NUMBER OF TWO OF THE CYPHERS INITIALLY IMPLANTED TO TREAT THE SVG-DIAGONAL LESION IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. (B)(4): 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 13345377 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4): 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 15052825 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MYOCARDIAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION 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 OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. 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 LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND TREATMENT OF SAPHENOUS VEIN GRAFTS. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE IN-STENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT, PROCEDURAL, AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.
THIS DEVICE IS ONE OF FOUR PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 3003742446-2010-00429, 3003742446-2010-00430, 3003742446-2010-00443, AND 3003742446-2011-00024. INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY THAT 20 MONTHS POST IMPLANTATION OF THREE UNKNOWN CYPHER STENTS TO TREAT TANDEM LESIONS IN A SAPHENOUS VEIN GRAFT (SVG) - DIAGONAL, A RESTENOSIS OF ONE OF THE STENTS (CXS13275 LOT 13345377) IN THE MID PORTION WAS TREATED WITH ANOTHER. A CUTTING BALLOON AND IMPLANTATION OF ANOTHER CYPHER STENT (CXS 18300 LOT 15052825). POST TREATMENT OF THE RESTENOSIS, THE PATIENT HAD ELEVATED ENZYMES AND CK-MB WAS 3 TIMES THE UPPER NORMAL LIMIT. TEN MONTHS LATER, THE PATIENT RETURNED WITH A MYOCARDIAL INFARCTION. ONE OF THE PREVIOUSLY IMPLANTED CYPHER STENTS HAD RESTENOSIS. IT WAS INDICATED THAT THE RESTENOSED PORTION WAS PROBABLY WITHIN 5MM OF ALL OF THE IMPLANTED CYPHER STENTS. IN ADDITION THERE WAS NEW LESION FORMATION IN THE SVG ANASTOMOSIS TO THE FIRST OBTUSE MARGINAL BRANCH. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY. PRIOR TO STUDY ENROLLMENT THE (B)(6) FEMALE HAD A HISTORY OF ANGINA WITHOUT POSITIVE FUNCTION STUDY FOR ISCHEMIA WITHIN THE PAST SIX WEEKS. SHE HAD A MEDICAL HISTORY OF FOUR PREVIOUS PCIS, AND CABG, HYPERLIPIDEMIA, AND MYOCARDIAL INFARCTION; THE LATEST WAS A YEAR AND A HALF PREVIOUS TO INDEX PROCEDURE. ASPIRIN AND CLOPIDOGREL WERE ADMINISTERED PRE-PROCEDURE AND POST PROCEDURE. AT INDEX PROCEDURE OF THE INITIAL RESTENOSIS THE DIAMETER STENOSIS WAS 90% AND REFERENCE VESSEL DIAMETER WAS 3MM WITH A LESION LENGTH OF 15MM WITHOUT HEAVY CALCIFICATION. PREDILATION WAS PERFORMED WITH A 2.5X10 NONCORDIS BALLOON. THE 3.0X13MM CYPHER STENT WAS IMPLANTED AT 20 ATM WHICH IS ABOVE THE RATED BURST PRESSURE OUTLINED IN THE INSTRUCTIONS FOR USE. THERE WERE NO ASSOCIATED ADVERSE EVENTS, PRODUCT DELIVERY DIFFICULTIES OR MALFUNCTIONS. THE RESIDUAL STENOSIS WAS 0% WITH TIMI III. PEAK CK-MB WAS 14 (UPPER LIMIT 3.2NG/ML) AND TROPONIN I 2.4 (UPPER LIMIT 0.4NG/ML). THE PATIENT WAS DISCHARGED ON THE THIRD DAY POST PROCEDURE. AT 30 DAY AND 60 DAY FOLLOW-UP THERE WAS NO ANGINA OR ADVERSE EVENTS WITHOUT INTERRUPTION OF ANTIPLATELET THERAPY. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE INITIAL TREATMENT OF THE SVG-DIAGONAL OR THE RESTENOSIS POST STUDY INDEX PROCEDURE. THE STENTS REMAIN IMPLANTED AND THEREFORE ARE NOT AVAILABLE FOR ANALYSIS. (B)(4): THE LOT NUMBER OF TWO OF THE CYPHERS INITIALLY IMPLANTED TO TREAT THE SVG-DIAGONAL LESION IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. (B)(4): 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 13345377 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4): 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 15052825 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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 LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND TREATMENT OF SAPHENOUS VEIN GRAFTS. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE IN-STENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT, PROCEDURAL, AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN
THIS DEVICE IS ONE OF FOUR PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 3003742446-2010-00429, 3003742446-2010-00430, 3003742446-2010-00443, AND 3003742446-2011-00024. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
THIS DEVICE IS ONE OF FOUR PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 3003742446-2010-00429, 3003742446-2010-00430, 3003742446-2010-00443, AND 3003742446-2011-00024. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
THE PATIENT RECEIVED 3 CYPHER STENTS TO TREAT A TANDEM LESION IN A SAPHENOUS VEIN GRAFT IN THE DIAGONAL ON (B)(6) 2008. THE 3 CYPHER STENTS WERE PLACED IN THE PROXIMAL TO DISTAL PORTIONS OF THE LESION. PATIENT CAME IN ON (B)(6) 2010 WITH RESTENOSIS OF ONE OF THE PREVIOUSLY IMPLANTED CYPHER STENTS IN THE MID PORTION. THE CATALOG AND LOT NUMBER OF THE RESTENOSED STENT WAS PROVIDED (CXS13275 LOT 13345377). THE SITE COULD NOT CONFIRM IF THIS RESTENOSIS WAS WITHIN 5MM OF THE OTHER 2 IMPLANTED CYPHER STENTS, BUT IT WAS INDICATED THAT THEY MOST LIKELY WERE WITHIN 5MM OF THE RESTENOSIS. AT THIS POINT, THE PATIENT WAS TREATED WITH A CUTTING BALLOON AND RECEIVED ANOTHER CYPHER STENT (CXS 18300 LOT 15052825). POST PROCEDURE, THE PATIENT HAD ELEVATED ENZYMES AND CK-MB WAS 3 TIMES THE UPPER NORMAL LIMIT. ON (B)(6) 2010, THE PATIENT CAME BACK WITH AN MI. ONE OF THE PREVIOUSLY IMPLANTED CYPHER STENT SHAD RESTENOSED. AGAIN, THE SITE INDICATED THAT THE RESTENOSED PORTION WAS PROBABLY WITHIN 5MM OF ALL THE IMPLANTED CYPHER STENTS. IN ADDITION TO THE RESTENOSIS, THERE WAS NEW LESION FORMATION IN THE SVG ANASTOMOSIS TO THE FIRST OBTUSE MARGINAL BRANCH. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY.
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 | 15052825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R | ASPIRIN, CLOPIDOGREL |