CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00031
- Event Type
- Injury
- Date Received
- January 13, 2011
- Date of Event
- February 5, 2010
- Report Date
- December 16, 2010
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
THE NOTIFICATION RECEIVED FOR THE (B)(4) STUDY INDICATED THAT THERE WAS A DISSECTION DURING THE INDEX PROCEDURE IN WHICH A CYPHER STENT WAS IMPLANTED. THE TARGET LESION IN THE (B)(6) MALE WAS THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS DE NOVO, NOT CALCIFIED OR TORTUOUS. THE RATE OF STENOSIS WAS 90%. THE LESION WAS PRE-DILATED WITH A 2.5MM BALLOON. A CYPHER (CWS23300/ LOT 15057436) WAS IMPLANTED AT THE TARGET SITE AT 22 ATMOSPHERES (ATMS). THIS IS ABOVE THE RATED BURST OF 16 ATM. THE INSTRUCTIONS FOR USE PRECAUTIONS NOT TO EXCEED THE RATED BURST OF 16 ATM. USE OF PRESSURES HIGHER THAN RATED BURST MAY RESULT IN RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION. THE STENT WAS POST-DILATED AS PER STANDARD PROCEDURE. IT WAS NOTED THAT AN EDGE DISSECTION OCCURRED AFTER PLACEMENT. THEREFORE A CYPHER CWS08300/ LOT 15065126) STENT WAS PLACED OVERLAPPING, DISTAL TO THE INITIAL STENT, AND A CYPHER (CWS08300/ LOT 15057435) STENT WAS PLACED OVERLAPPING, PROXIMAL TO THE INITIAL STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. THE STENT REMAINS IMPLANTED AND THEREFORE IS NOT AVAILABLE 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 THE LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PCI. IN THE PRECAUTIONS SECTION OF THE IFU IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ADDITIONAL INTERVENTION, I.E. PLACEMENT OF ADDITIONAL STENTS. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THIS IS AN INHERENT RISK OF THE PROCEDURE. VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS INCLUDING INFLATION ABOVE THE RATED BURST MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE OF ANY MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.
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.
THIS SUPPLEMENTAL REPORT IS BEING AS THE CORRECT EVENT DATE OF THE DISSECTION IS (B)(6) 2010, NOT (B)(6) 2010 AS ORIGINALLY REPORTED. THE DISSECTION OCCURRED DURING THE INDEX PROCEDURE ON (B)(6) 2010. TWO ADDITIONAL CYPHER STENTS WERE PLACED TO TREAT THE DISSECTION. THE PATIENT RETURNED ON (B)(6), 2010 FOR A RECHECK OF THE STENTS AND THE STENTS WERE PATENT.
THE NOTIFICATION RECEIVED FOR THE (B)(4) STUDY INDICATED THAT THERE WAS A DISSECTION DURING THE INDEX PROCEDURE. APPROXIMATELY 7 MONTHS POST PROCEDURE, THE PATIENT SUFFERED IN-STENT RESTENOSIS. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING HISTORY OF ANGINA, HISTORY OF HYPERLIPIDEMIA, HISTORY OF HYPERTENSION, HISTORY OF DIABETES MELLITUS, AND HISTORY OF SMOKING. THE TARGET LESION WAS THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS DE NOVO, NOT CALCIFIED OR TORTUOUS. THE RATE OF STENOSIS WAS 90%. THE LESION WAS PRE-DILATED WITH A 2.5MM BALLOON. A CYPHER (CWS23300/ LOT 15057436) WAS IMPLANTED AT THE TARGET SITE AT 22 ATMOSPHERES (ATMS). THIS IS ABOVE THE RATED BURST OF 16 ATM. THE INSTRUCTIONS FOR USE PRECAUTIONS NOT TO EXCEED THE RATED BURST OF 16 ATM. USE OF PRESSURES HIGHER THAN RATED BURST MAY RESULT IN RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION. THE STENT WAS POST-DILATED AS PER STANDARD PROCEDURE. IT WAS NOTED THAT AN EDGE DISSECTION OCCURRED AFTER PLACEMENT. THEREFORE A CYPHER (CWS08300/ LOT 15065126) STENT WAS PLACED OVERLAPPING, DISTAL TO THE INITIAL STENT, AND A CYPHER (CWS08300/ LOT 15057435) STENT WAS PLACED OVERLAPPING, PROXIMAL TO THE INITIAL STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. AT THE 30 DAY FOLLOW UP, THERE WAS STABLE ANGINA REPORTED. ANGIOGRAPHY WAS PERFORMED. NO ADDITIONAL TREATMENT WAS REPORTED. DUAL ANTI-PLATELET THERAPY WAS CONTINUOUS. AT THE 6 MONTH FOLLOW UP, THERE WAS NO ANGINA REPORTED. DUAL ANTI-PLATELET THERAPY WAS CONTINUOUS. APPROXIMATELY 7 MONTHS POST PROCEDURE, THE PATIENT SUFFERED IN-STENT RESTENOSIS. TO DATE, DESPITE EFFORTS, NO FURTHER INFORMATION HAS BEEN AVAILABLE REGARDING THE TREATMENT OF THE IN-STENT RESTENOSIS. AT THE TWELVE MONTH FOLLOW UP, NO ANGINA WAS REPORTED. DUAL ANTI-PLATELET THERAPY WAS CONTINUOUS. AT THE 15 AND 18 MONTH FOLLOW UPS, NO ANGINA WAS REPORTED. THE INDEX STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. 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 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. 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. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 3003742446-2011-00031, 3003742446-2011-00418, AND 3003742446-2011-00419.
ADDITIONAL INFORMATION RECEIVED FROM THE (B)(4) STUDY DATABASE NOTED THAT AN IN-STENT RESTENOSIS WAS DIAGNOSED. A CYPHER ((B)(4) / LOT 15057436) WAS IMPLANTED AT THE TARGET SITE AT 22 ATMOSPHERES (ATMS). THE STENT WAS POST-DILATED AS PER STANDARD PROCEDURE. IT WAS NOTED THAT AN EDGE DISSECTION OCCURRED AFTER PLACEMENT. THEREFORE A CYPHER ((B)(4) / LOT 15065126) STENT WAS PLACED OVERLAPPING, DISTAL TO THE INITIAL STENT, AND A CYPHER ((B)(4) / LOT 15057435) STENT WAS PLACED OVERLAPPING, PROXIMAL TO THE INITIAL STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE AN IN-STENT RESTENOSIS WAS DIAGNOSED AND REVASCULARIZATION WAS PERFORMED. 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 THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2011-00031, 3003742446-2011-00418, AND 3003742446-2011-00419.
THE NOTIFICATION RECEIVED FOR THE (B)(4) STUDY INDICATED THAT THE PATIENT HAD A DISSECTION. THE PATIENT IS A (B)(6) MALE. ON (B)(6) 2010 THE INDEX PROCEDURE TOOK PLACE. THE TARGET LESION LOCATION WAS THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS DE NOVO. NOT CALCIFIED OR TORTUOUS. THE RATE OF STENOSIS WAS 90%. THE LESION WAS PRE-DILATED WITH A 2.5MM BALLOON. A CYPHER ((B)(4)/ LOT 15057436) WAS IMPLANTED AT THE TARGET SITE AT 22 ATMOSPHERES (ATMS). THE STENT WAS POST-DILATED AS PER STANDARD PROCEDURE. IT WAS NOTED THAT AN EDGE DISSECTION OCCURRED AFTER PLACEMENT. THEREFORE A (CYPHER ((B)(4)/ LOT 15065126) STENT WAS PLACED OVERLAPPING, DISTAL TO THE INITIAL STENT, AND A (CYPHER ((B)(4)/ LOT 15057435) STENT WAS PLACED OVERLAPPING, PROXIMAL TO THE INITIAL STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED.
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 | 15057436 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| L| R |