CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00210
- Event Type
- Injury
- Date Received
- April 28, 2011
- Date of Event
- January 30, 2011
- Report Date
- April 1, 2011
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
(B)(6) 2011 09:35 24 HR CLOCK: CK 181 (UL: 225 U/L), CK-MB 18 (UL: 16 U/L), TROPONIN I 0.012 (UL: 0.034 NG/ML). (B)(6) 2011 05:55 24 HR CLOCK: CK 120 (UL: 225 U/L), CK-MB 8 (UL: 16 U/L), TROPONIN I 0.023 (UL: 0.034 NG/ML). (B)(6) 2011 16:46 24 HR CLOCK: CK 153 (UL: 225 U/L), CK-MB 10 (UL: 16 U/L) AND (B)(6) 2011 09:35 24 HR CLOCK: CK 181 (UL: 225 U/L), CK-MB 18 (UL: 16 U/L), TROPONIN I 0.012 (UL: 0.034 NG/ML). ASPIRIN 325MG START DATE: (B)(6) 2011 "ONGOING, METFORMIN 750MG START DATE: (B)(6) 2010" ONGOING AND ENALAPRIL 80MG (START DATE (B)(6) 2011). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
THE COMPLAINT RECEIVED STATES THIS (B)(4) STUDY PATIENT EXPERIENCED MULTIPLE EVENTS OF INSTENT RESTENOSIS AND CHEST PAIN POST INDEX PROCEDURE. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING DYSLIPIDEMIA, HYPERTENSION, DIABETES AND MULTIPLE PCIS. THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT APPROXIMATELY 12 YEARS PRIOR TO THE INDEX PROCEDURE, THE PATIENT HAD TWO PALMAZ SCHATZ STENTS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). THE INDICATION FOR THE INDEX PROCEDURE WAS POSITIVE FUNCTIONAL STUDY AND STABLE ANGINA. THE TARGET LESION WAS AN 80% STENOSIS OF THE PROXIMAL RCA. IN (B)(6) 2010, THE INDEX PROCEDURE WAS PERFORMED. ONE TARGET LESION AND ONE NON-TARGET LESION WERE TREATED DURING THE PROCEDURE. THE TARGET LESION IN THE PROXIMAL RCA WAS PRE-DILATED AND ONE STUDY STENT WAS IMPLANTED WITHOUT REPORT OF PROBLEMS. THE CORE LAB REPORTED A 15% RESIDUAL STENOSIS, TIMI 3 FLOW AND NO DISSECTION. THE LCX NON-TARGET LESION WAS PRE-DILATED AND ONE NON-STUDY STENT WAS IMPLANTED WITHOUT REPORT OF DIFFICULTIES. THE POST PROCEDURE COURSE WAS UNCOMPLICATED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON DUAL ANTI-PLATELET THERAPY. IN (B)(6) 2011, THE PATIENT PRESENTED WITH INTERMITTENT CHEST PAIN TIMES 3-4 DAYS. DUAL ANTI-PLATELET THERAPY HAD BEEN CONTINUOUS. ANGIOPLASTY REVEALED A TUBULAR 90% INSTENT RESTENOSIS OF THE PROXIMAL RCA, A 30% DIFFUSE LESION IN THE DISTAL RCA AND A 70% PROXIMAL 1ST OM LESION. THE CORE LAB REPORTED A 79% DIFFUSE PROLIFERATIVE IN-STENT RESTENOSIS OF TYPE III WITH NO THROMBOSIS AND TIMI 3 FLOW, NOTING TARGET LESION REVASCULARIZATION. SUCCESSFUL UNCOMPLICATED TREATMENT OF THE PROXIMAL RCA RESTENOSIS WITH PLACEMENT OF ONE NON-STUDY DES AND POST DILATION WAS REPORTED. AT THE 12 MONTH FOLLOW-UP INTERVIEW, THE PATIENT REPORTED STABLE ANGINA. IN (B)(6) 2011, APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE; THE PATIENT HAD TARGET LESION REVASCULARIZATION IN THE PROXIMAL RCA WITH BALLOON ANGIOPLASTY DUE TO POSITIVE ISCHEMIC FUNCTION STUDY. IN (B)(6) 2011, RESTENOSIS WAS REPORTED IN THE PROXIMAL RCA AND WAS 70-80% OBSTRUCTED. HOWEVER, THIS WAS IN A XIENCE V STENT PREVIOUSLY PLACED THERE AND IT WAS TREATED WITH POBA. THE CORDIS STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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. CHEST PAIN IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE CYPHER IFU AS SUCH. 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. THE NATURAL PROGRESSION OF CORONARY DISEASE AS WELL AS TARGET LESION ISSUES MAY CONTRIBUTE TO THE EXPERIENCE OF CHEST PAIN / ANGINA. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT 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. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND DIABETES.
AT 18 MONTHS POST INDEX PROCEDURE, THE PATIENT HAD TARGET LESION REVASCULARIZATION IN THE PROXIMAL RCA WITH BALLOON ANGIOPLASTY DUE TO POSITIVE ISCHEMIC FUNCTION STUDY. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
CONCOMITANT MEDICAL PRODUCTS: HYOMAX 0.735MG, ASPIRIN 325MG ((B)(6) 2010), ENALAPRIL 40MG, ACTOS 30MG, METOPROLOL 100MG, ZETIA 10MG, LIPITOR 40MG, METFORMIN 1000MG, NORVASC 5MG, HYDROCHLORTHIAZIDE 25MG, PLAVIX 150MG ((B)(6) 2010) AND PLAVIX 75MG ((B)(6) 2010). INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT WITH MULTIPLE PRIOR PERCUTANEOUS INTERVENTIONS EXPERIENCED RESTENOSIS AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, ISCHEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, DIABETES AND AN UNKNOWN ALLERGY. THE PATIENT HAS HAD SEVEN INTERVENTION PERFORMED BETWEEN 1993- 2011, WITH A TOTAL OF NINE CATHETERIZATIONS. THE FIRST CARDIAC CATHETERIZATION IN 1993 REVEALED A 70% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD), 90% STENOSIS IN THE 2ND OBTUSE MARGINAL (OM), 90% STENOSIS IN THE POSTERIOR DESCENDING ARTERY (PDA), 70% STENOSIS IN OM1 AND 90% STENOSIS ON THE RIGHT PDA. THE PATIENT HAD SUCCESSFUL ANGIOPLASTY PERFORMED THE FOLLOWING DAY TO THE PDA AND OM2. IN 1997, THE PATIENT RECEIVED TWO PALMAZ SCHATZ STENTS TO THE MID RIGHT CORONARY ARTERY (RCA). IN 2000, THE PATIENT RECEIVED A 3.0MM X 18MM VELOCITY TO AN 80% MID LAD LESION. IN 2001, ANGINA INSPIRED ANGIOGRAPHY REVEALED 30% PROXIMAL RCA STENOSIS, 30% RPDA STENOSIS, AND 80% MID LAD RESTENOSIS. THE RESTENOSIS OF THE VELOCITY WAS TREATED WITH BALLOON ANGIOPLASTY. IN 2010, ENROLLMENT INTO THE STUDY, THE PATIENT HAD A 3.5MM X 18MM CYPHER STENT IMPLANTED IN THE PROXIMAL RCA AND A PROMUS STENT IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (CFX). THE RCA WAS DESCRIBED AS DE NOVO, 14MM LONG 80% STENOSED AND MILDLY CALCIFIED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 3.5MM X 18MM CYPHER STENTS AT 20 ATMS. THE STENT WAS NOT POST-DILATED AND THE REPORTED RESIDUAL STENOSIS WAS 0%. APPROXIMATELY TEN MONTHS LATER, DUE TO EXERTIONAL ANGINA, ANGIOGRAPHY WAS PERFORMED AND REVEALED RESTENOSIS IN THE PROXIMAL RCA THAT WAS TREATED WITH THE IMPLANT OF A 3.0MM X 18MM XIENCE STENT. BECAUSE IT IS OUR INTENT TO REPORT CONSERVATIVELY AND THE PROXIMITY OF THE PALMAZ STENTS TO THE PROXIMAL RCA LESION AND STENT IS UNKNOWN, RESTENOSIS WILL BE CAPTURED ON THOSE STENTS ALSO. THE DHR FOR THE CYPHER STENT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND THE PROGRESSION OF CORONARY ARTERY DISEASE. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S EXTENSIVE HISTORY OF CORONARY ARTERY DISEASE IN CONJUNCTION WITH FAMILY HISTORY, HYPERTENSION AND DIABETES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN. THIS IS ONE OF FOUR PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURER REPORT NUMBERS 3003742446-2011-00210, 9616099-2011-00376, 9616099-2011-00377 AND 1016427-2011-00044.
PLEASE NOTE THE EVENT DATE IS UNKNOWN. THERE WERE NO ANGIOGRAPHIC COMPLICATIONS OR PRODUCT MALFUNCTIONS. THE SECOND LESION TREATED WAS A 70% STENOSIS IN THE PROXIMAL CIRCUMFLEX. THE LESION WAS DE NOVO AND 14MM LONG. THE LESION WAS PRE-DILATED AND A 3.0 X 18MM PROMUS STENT WAS SUCCESSFULLY DEPLOYED WITH NO ANGIOGRAPHIC COMPLICATIONS. THE PATIENT WAS DISCHARGED WITH NO ANGINA OR MAJOR ADVERSE EVENTS. THE PATIENT HAD NO ANGINA DURING THE 30 DAYS AND 6 MONTH FOLLOW UP. CONCOMITANT MEDICAL PRODUCTS: HYOMAX 0.735MG, ASPIRIN 325MG ((B)(6) 2010), ENALAPRIL 40MG, ACTOS 30MG, METOPROLOL 100MG, ZETIA 10MG, LIPITOR 40MG, METFORMIN 1000MG, NORVASC 5MG, HYDROCHLORTHIAZIDE 25MG, PLAVIX 150MG ((B)(6) 2010) AND PLAVIX 75MG ((B)(6) 2010). THE PRODUCT IS 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 15112637 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE 1ST EVENT OF ANGINA WAS UNSTABLE ANGINA. THE EVENT START AND STOP DATE IS (B)(6) 2011. THE REFERENCE VESSEL IS THE PROXIMAL RIGHT CORONARY ARTERY. THE LESION LOCATION WAS NATIVE AND WAS TREATED WITH A PCI, DRUG-ELUTING STENT. THE REVASCULARIZATION WAS SUCCESSFUL. THE REVASCULARIZATION WAS DRIVEN BY ANGIOGRAPHIC EVIDENCE. THE EVENT RESOLVED WITHOUT SEQUELAE. THE EVENT WAS REPORTED TO BE POSSIBLY RELATED TO THE CYPHER STENT. THE SECOND EVENT OF ANGINA WAS ALSO UNSTABLE ANGINA. THE START DATE OF THE EVENT WAS (B)(6) 2011 AND THE STOP DATE WAS (B)(6) 2011. THE EVENT WAS REPORTED TO BE SEVERE AND WAS TREATED WITH PTCA. THE REFERENCE VESSEL IS THE PROXIMAL RIGHT CORONARY ARTERY. THE SUBJECT WAS ON ANTI-PLATELET THERAPY 24 HOURS PRIOR TO THE EVENT.
THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT ON AN UNKNOWN TIME PERIOD AFTER THE INDEX PROCEDURE, THE PATIENT HAD ANGINA THAT LED TO A REVASCULARIZATION/PTCA. THE EVENT WAS REPORTED TO BE SEVERE. THE EVENT RESOLVED WITHOUT SEQUELAE AND WAS REPORTED TO BE POSSIBLY RELATED TO THE INDEX PROCEDURE AND STUDY DRUG AND PROBABLY RELATED TO THE CYPHER STENT. A SECOND EVENT OF ANGINA THAT OCCURRED ON AN UNKNOWN TIME PERIOD AFTER THE INDEX PROCEDURE WAS REPORTED. THIS EVENT WAS TREATED WITH PTCA AND RESOLVED WITHOUT SEQUELAE. THE EVENT WAS REPORTED TO BE POSSIBLY RELATED TO THE INDEX PROCEDURE, CYPHER STENT AND THE STUDY DRUG. IT WAS ALSO REPORTED THAT THE PATIENT HAD STABLE ANGINA DURING THE 12 MONTHS FOLLOW UP. CK-MB WAS NOTICED TO BE SLIGHTLY ELEVATED PRE AND POST-PROCEDURE. REGARDING THE INDEX PROCEDURE, THE PATIENT WAS TREATED WITH AN 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS DE NOVO, TYPE B1, 14MM LONG, WITH MILD CALCIFICATION AND NO VESSEL TORTUOSITY. THE LESION WAS PRE-DILATED WITH A 3.0 X 15MM BALLOON AT 20ATM WITH A NON-CORDIS BALLOON. A 3.5 X 18MM CYPHER STENT WAS DEPLOYED AT 20ATM SUCCESSFULLY.
ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED APPROXIMATELY 12 YEARS PRIOR TO THE INDEX PROCEDURE, THE PATIENT HAD TWO PALMAZ SCHATZ STENTS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). DURING INDEX PROCEDURE, THE PATIENT WAS TREATED WITH AN 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS DE NOVO, TYPE B1, 14MM LONG, WITH MILD CALCIFICATION AND NO VESSEL TORTUOSITY. THE LESION WAS PRE-DILATED WITH A 3.0 X 15MM BALLOON AT 20ATM WITH A NON-CORDIS BALLOON. A 3.5 X 18MM CYPHER STENT WAS DEPLOYED AT 20ATM SUCCESSFULLY. THERE WERE NO ANGIOGRAPHIC COMPLICATIONS OR PRODUCT MALFUNCTIONS. APPROXIMATELY 10 YEARS PRIOR TO THE INDEX PROCEDURE, THE PATIENT HAD A 3.0 X 18MM BX VELOCITY STENT IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). APPROXIMATELY FIVE MONTHS LATER, THE PATIENT HAD 80% IN-STENT RESTENOSIS OF THE BX VELOCITY STENT.
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 | 15112637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| L| R | HEPARIN 7000 UNITS| ASPIRIN 81MG |