CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00104
- Event Type
- Injury
- Date Received
- February 25, 2011
- Date of Event
- September 7, 2011
- Report Date
- September 17, 2012
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00104, 3003742446-2011-00105 AND 3003742446-2011-00106. A (B)(6) FEMALE FROM THE (B)(4) STUDY EXPERIENCED RESTENOSIS APPROXIMATELY A YEAR AFTER IMPLANTATION OF THREE CYPHER STENTS. THE PATIENT'S MEDICAL HISTORY CONSISTED OF HYPERTENSION, HISTORY OF MYOCARDIAL INFARCTION, FAMILY HISTORY OF CORONARY ARTERY DISEASE AND CURRENT SMOKER. AT STUDY ENROLLMENT, THE PATIENT HAD AN 80%, DE NOVO, TYPE C LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS 45MM IN LENGTH AND THE VESSEL WAS 2.5MM IN DIAMETER. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. THE LESION WAS PRE-DILATED AND THREE CYPHER STENTS WERE IMPLANTED. A 2.5 X 23MM CYPHER STENT WAS IMPLANTED AT 16ATM IN THE MID LEFT ANTERIOR DESCENDING ARTERY, A 2.5 X 8MM CYPHER STENT WAS IMPLANTED AT 18ATM OVERLAPPING THE DISTAL EDGE AND FINALLY A 3.0 X 18MM CYPHER STENT WAS IMPLANTED AT 16ATM OVERLAPPING THE PROXIMAL EDGE OF THE INITIAL STENT. APPROXIMATELY TWELVE MONTHS POST INDEX PROCEDURE, THE PATIENT REPORTED STABLE ANGINA. IT WAS NOTED THAT THERE WAS IN-STENT RESTENOSIS IN THE PREVIOUSLY IMPLANTED STENTS. THE PATIENT HAD A REVASCULARIZATION DONE. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS, VESSEL/LESION FACTORS (LONG LESION) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.
COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT APPROXIMATELY ONE YEAR POST INDEX PROCEDURE THE PATIENT REPORTED ANGINA AND ANGIOGRAPHY REVEALED INSTENT RESTENOSIS. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING HYPERTENSION, HISTORY OF MYOCARDIAL INFARCTION ((B)(6) 2008), FAMILY HISTORY OF CORONARY ARTERY DISEASE AND CURRENT SMOKER. THE PATIENT WAS ENROLLED IN THE CYPRESS STUDY WITH AN 80%, DE NOVO, TYPE C LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS 45MM IN LENGTH AND THE VESSEL WAS 2.5MM IN DIAMETER. THE LESION WAS PRE-DILATED AND THREE CYPHER STENTS WERE IMPLANTED. A 2.5 X 23MM CYPHER STENT WAS IMPLANTED AT 16ATM IN THE MID LEFT ANTERIOR DESCENDING ARTERY, A 2.5 X 8MM CYPHER STENT WAS IMPLANTED AT 18ATM OVERLAPPING THE DISTAL EDGE AND FINALLY A 3.0 X 18MM CYPHER STENT WAS IMPLANTED AT 16ATM OVERLAPPING THE PROXIMAL EDGE OF THE INITIAL STENT. THE PATIENT WAS DISCHARGED ON DUAL ANTI-PLATELET THERAPY. ADDITIONAL INFORMATION RECEIVED FROM THE SITE INDICATED THAT THE PATIENT UNDERWENT PTCA OF THE TARGET VESSEL MLAD DUE TO CLASS III ANGINA. THERE WAS A FOCAL LESION IN THE MID STENT. A 2.5 BY 10MM ANGIO SCULP BALLOON WAS USED. THE LENGTH WAS 8MM & THE RESTENOSIS WAS 60-70%. THE OTHER STENTS WERE PATENT. PER PHYSICIAN, THE LESION WAS WITHIN 5MM OF DISTAL 2.5X8MM STENT. IT WAS RIGHT AT THE INTERFACE OF THE DISTAL OVERLAP SITE. THERE WERE NO STENTS PLACED ON (B)(6) 2010. THE OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUELAE. THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENTS, INDEX PROCEDURE, AND STUDY DRUG. THE STUDY 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. REVIEW OF LOT 14155929 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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 SMOKING. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00104 AND 3003742446-2011-00105.
A FIRESTAR BALLOON 3.0 X 20MM WAS USED DURING THE INDEX PROCEDURE. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00104, 3003742446-2011-00105 AND 3003742446-2011-00106. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.
ADDENDUM: ADDITIONAL INFORMATION RECEIVED FROM THE SITE INDICATED THAT THE PATIENT UNDERWENT PTCA OF THE TARGET VESSEL MLAD DUE TO CLASS III ANGINA. THERE WAS A FOCAL LESION IN THE MID STENT. A 2.5 BY 10MM ANGIO SCULP BALLOON WAS USED. THE LENGTH WAS 8MM & THE RESTENOSIS WAS 60-70%. THE OTHER STENTS WERE PATENT. PER PHYSICIAN, THE LESION WAS WITHIN 5MM OF DISTAL 2.5X8MM STENT. IT WAS RIGHT AT THE INTERFACE OF THE DISTAL OVERLAP SITE. THERE WERE NO STENTS PLACED ON (B)(6) 2010. THE OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUELAE. THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENTS, INDEX PROCEDURE, AND STUDY DRUG.
APPROXIMATELY TWELVE MONTHS POST INDEX PROCEDURE, THE PATIENT REPORTED STABLE ANGINA. IT WAS NOTED THAT THERE WAS IN-STENT RESTENOSIS IN THE PREVIOUSLY IMPLANTED STENTS. THE PATIENT HAD A REVASCULARIZATION DONE. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY WITH AN 80%, DE NOVO, TYPE C LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS 45MM IN LENGTH AND THE VESSEL WAS 2.5MM IN DIAMETER. THE LESION WAS PRE-DILATED AND THREE CYPHER STENTS WERE IMPLANTED. A 2.5 X 23MM CYPHER STENT WAS IMPLANTED AT 16ATM IN THE MID LEFT ANTERIOR DESCENDING ARTERY, A 2.5 X 8MM CYPHER STENT WAS IMPLANTED AT 18ATM OVERLAPPING THE DISTAL EDGE AND FINALLY A 3.0 X 18MM CYPHER STENT WAS IMPLANTED AT 16ATM OVERLAPPING THE PROXIMAL EDGE OF THE INITIAL 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 | 14155929 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R |