CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00391
- Event Type
- Injury
- Date Received
- August 24, 2011
- Date of Event
- April 15, 2011
- 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
- SC, US
- Reporter Occupation
- OTHER
Narratives
AT THE THIRTY-DAY (30) DAY FOLLOW-UP CONTACT, THE PATIENT WAS REPORTED TO HAVE STABLE ANGINA. AT THE SIX (6) MONTH FOLLOW-UP CONTACT, THE PATIENT WAS REPORTED TO HAVE UNSTABLE ANGINA. THE FIRST OM TARGET LESION WAS REPORTED TO BE: DE NOVO, 2.5 MM VESSEL DIAMETER, A 99% STENOSIS, 15 MM LENGTH, PROXIMAL, SEVERELY TORTUOUS, NOT CALCIFIED, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.5 X 12 MM BALLOON CATHETER AT 14 ATM. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE-PROCEDURE WAS TIMI 2 AND POST-PROCEDURE TIMI 3. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT #3003742446-2011-00390 AND #3003742446-2011-00391.
ADDITIONAL INFORMATION RECEIVED VIA THE CEC ADJUDICATION COMMITTEE ON 1/13/2012 INDICATED THAT ON (B)(6) 2011, THE CATHETERIZATION REPORT NOTED THE 1ST OM WAS OCCLUDED AT THE OSTIUM AND THE ANGIOGRAPHIC CORE LAB REPORTED A TOTALLY OCCLUDED TARGET LESION IN THE 1ST OM (IN-STENT RESTENOSIS PATTERN SIV) WITH TIMI 0 FLOW AND NO EVIDENCE OF THROMBUS. THE PREVIOUSLY REPORTED THROMBUS SHOULD BE DELETED AND CORONARY ARTERY RESTENOSIS WILL REMAIN. THE CEC COMMITTEE ALSO FELT THERE WAS NO MI ASSOCIATED WITH THE EVENT. UPDATED COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT SUFFERED IN-STENT RESTENOSIS APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE. THIS IS A (B)(6) FEMALE PATIENT WITH MEDICAL HISTORY INCLUDING MI (B)(6) 2010, PCI X3, DYSLIPIDEMIA, HYPERTENSION, LVEF 40 - 50%, COPD, DIABETES AND EX-SMOKER. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA WITH A 99% STENOSIS IN THE 1ST OM. IN (B)(6) 2010, THE INDEX PROCEDURE WAS PERFORMED. THE LESION WAS PRE-DILATED AND TWO CYPHER STENTS WERE IMPLANTED IN OVERLAPPING FASHION. THE ANGIOGRAPHIC CORE LAB REPORTED ABRUPT CLOSURE FOLLOWING WIRE INTRODUCTION, THE VESSEL REOPENED AND WAS STENTED WITH GOOD FINAL RESULT. THE CORE LAB REPORTED 14% RESIDUAL STENOSIS, NO DISSECTION AND TIMI 3 FLOW. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON DUAL ANTI-PLATELET THERAPY. IN (B)(6) 2011, THE PATIENT PRESENTED WITH ANGINA AND ANGIOGRAPHY WAS PERFORMED. THE 1ST OM STENTS WERE OCCLUDED AT THE OSTIUM, IN-STENT RESTENOSIS PATTERN IV, TIMI 0 FLOW AND NO EVIDENCE OF THROMBOSIS. POBA WAS SUCCESSFULLY PERFORMED ON THE RESTENOSIS WITH RESTORATION OF FLOW, NO DISSECTION AND 10% RESIDUAL STENOSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO 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 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. 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, DIABETES AND SMOKING. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORTS #3003742446-2011-00390 AND #3003742446-2011-00391.
INFORMATION RECEIVED FROM THE CYPRESS STUDY INDICATED THAT A PATIENT EXPERIENCED A THROMBOTIC EVENT AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, PREVIOUS PCI (B)(6) 2010, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, CHRONIC PULMONARY DISEASE, DIABETES, PAST SMOKING, AND GERD. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE TARGET LESION WAS THE FIRST OBTUSE MARGINAL; THE LESION WAS DESCRIBED AS PROXIMAL, DE NOVO, AND SEVERELY TORTUOUS. THE LESION WAS PRE-DILATED WITH TWO BALLOONS PRIOR TO THE IMPLANT OF A 2.5MMX 18MM CYPHER STENT AT 14 ATMS. THE STENT WAS NOT POST-DILATED AND WAS THEN FOLLOWED BY THE IMPLANT OF A 2.5MM X13 MM CYPHER STENT AT 16ATMS PROXIMAL AND OVERLAPPING THE FIRST, TO FULLY COVER THE LESION. THE STENTS WERE NOT POST-DILATED AND THE RESIDUAL REPORTED STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE DAY AFTER THE INDEX PROCEDURE. APPROXIMATELY FOUR MONTHS LATER THE PATIENT EXPERIENCED ANGINA, ANGIOGRAPHY WAS PERFORMED AND REVEALED STENT THROMBOSIS. THE OSTIUM OF THE OBTUSE MARGINAL WAS 100% OCCLUDED. THE PROXIMAL CYPHER 2.5 X 13 MM STENT WAS RESTENOSED. THE EVENT WAS TREATED WITH BALLOON ANGIOPLASTY. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR INSPECTION. 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. LATE STENT THROMBOSIS AND RESTENOSIS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT VESSEL/LESION CHARACTERISTICS (EXTREMELY TORTUOUS) AND/OR PATIENT FACTORS (DIABETES, HYPERTENSION AND CHRONIC PULMONARY DISEASE) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED EVENT, NO ACTION WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #3003742446-2011-00390 AND #3003742446-2011-00391.
THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND WAS FOUND TO HAVE ONE VESSEL DISEASE AND HAD ONE TARGET LESION TREATED DURING THE STUDY INDEX PROCEDURE. THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION WAS FORTY TO FIFTY PERCENT (LVEF 40-50%). THE PATIENT HAD TWO CYPHER STENTS IMPLANTED: A 2.5 X 18 MM STENT, AND A 2.5 X 13MM STENT (PROXIMALLY) SUCCESSFULLY IMPLANTED IN OVERLAPPING FASHION IN THE FIRST OBTUSE MARGINAL (OM) TARGET LESION. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE INDEX PROCEDURE. APPROXIMATELY FOUR (4) MONTHS AFTER THE STUDY INDEX PROCEDURE, THE PATIENT WAS REPORTED TO HAVE AN ADVERSE EVENT (AE) OF STENT THROMBOSIS. THE OSTIUM OF THE OBTUSE MARGINAL WAS 100% OCCLUDED. THE PROXIMAL CYPHER 2.5 X 13 MM STENT WAS RESTENOSED. THE STENT THROMBOSIS/RESTENOSIS WAS TREATED BY BALLOON ANGIOPLASTY (PTCA)/RE-PERCUTANEOUS CORONARY INTERVENTION (RE-PCI). THE PATIENT WAS REPORTED TO BE COMPLIANT WITH THE ANTIPLATELET MEDICAL REGIMEN.
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 | 15261976 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization| L| R | 2.5 X 12 MM BALLOON CATHETER |