CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00058
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- April 19, 2011
- Report Date
- December 18, 2012
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00057 AND 3003742446-2011-00058. A (B)(6) MALE FROM THE (B)(4) STUDY EXPERIENCED RESTENOSIS APPROXIMATELY TEN MONTHS POST IMPLANTATION OF TWO CYPHER STENTS. PAST MEDICAL HISTORY INCLUDES ISCHEMIA, PREVIOUS CORONARY INTERVENTION, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, AND TYPE 2 DIABETES MELLITUS. THE TARGET LESIONS DURING THE INDEX PROCEDURE WERE LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DISTAL LAD. THE LESION IN THE MID LAD WAS DESCRIBED AS 60% STENOSED, DE NOVO, NON-THROMBOSED, 18MM IN LENGTH, TYPE A, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3X10MM DURASTAR PTCA BALLOON CATHETER AT 22ATMS. A 3.5X18MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 16ATMS. THE LESION WAS POST-DILATED WITH AN UNKNOWN 3X10MM BALLOON CATHETER AT 24ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WERE NOT PROVIDED. THE LESION IN THE DISTAL LAD WAS DESCRIBED AS 75% STENOSED, DE NOVO, NON-THROMBOSED, 18MM IN LENGTH, TYPE A, WITH MODERATE CALCIFICATION. THE REFERENCE VESSEL WAS 3MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 2X15MM DURASTAR PTCA BALLOON CATHETER AT 14ATMS. A 2.5X28MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 10ATMS. THE LESION WAS POST-DILATED WITH A 2X12MM UNKNOWN BALLOON CATHETER AT 10ATMS. RESIDUAL STENOSIS WAS 0%. NO DISSECTION OCCURRED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT APPROXIMATELY TEN MONTHS AFTER THE INDEX PROCEDURE, RESTENOSIS OF THE MID AND DISTAL LAD WAS NOTED. REVASCULARIZATION OF THE LAD WAS PERFORMED WITH THE IMPLANTATION OF A 2.5X18MM CYPHER RX STENT AND THE EVENT RESOLVED. 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 (SPECIFICALLY DIABETES) AND VESSEL/LESION FACTORS (CALCIFIED AND LONG LESION) 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.
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. CONCOMITANT DEVICES INCLUDE A 3X10MM AND 2X15MM DURASTAR BALLOON CATHETER. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00057 AND 3003742446-2011-00058. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00057, 3003742446-2011-00058, AND 3003742446-2011-00416. AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPERIENCED RESTENOSIS OF THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DISTAL LAD TEN MONTHS AFTER THE INDEX PROCEDURE. SIXTEEN MONTHS AFTER THE INDEX PROCEDURE, RESTENOSIS REOCCURRED WITH THE MID AND DISTAL LAD. PAST MEDICAL HISTORY INCLUDES ISCHEMIA, PREVIOUS CORONARY INTERVENTION, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, AND TYPE 2 DIABETES MELLITUS. THE TARGET LESIONS WERE LOCATED IN THE MID LAD AND DISTAL LAD. THE LESION IN THE MID LAD WAS DESCRIBED AS 60% STENOSED, DE NOVO, NON-THROMBOSED, 18MM IN LENGTH, TYPE A, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3X10MM DURASTAR PTCA BALLOON CATHETER AT 22ATMS. A 3.5X18MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 16ATMS. THE LESION WAS POST-DILATED WITH AN UNKNOWN 3X10MM BALLOON CATHETER AT 24ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WERE NOT PROVIDED. THE LESION IN THE DISTAL LAD WAS DESCRIBED AS 75% STENOSED, DE NOVO, NON-THROMBOSED, 18MM IN LENGTH, TYPE A, WITH MODERATE CALCIFICATION. THE REFERENCE VESSEL WAS 3MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 2X15MM DURASTAR PTCA BALLOON CATHETER AT 14ATMS. A 2.5X28MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 10ATMS. THE LESION WAS POST-DILATED WITH A 2X12MM NON-CORDIS BALLOON CATHETER AT 10ATMS. RESIDUAL STENOSIS WAS 0%. NO DISSECTION OCCURRED DURING THE PROCEDURE AND NO DISTAL DISEASE WAS LEFT UNTREATED. "HEALTHY TISSUE TO HEALTHY TISSUE" WAS COVERED BY THE STENTS. PRE AND POST PROCEDURE TIMI FLOW FOR THE MID AND DISTAL LAD WAS 3. THE PATIENT WAS COMPLIANT WITH ANTI-PLATELET THERAPY. TEN MONTHS AFTER THE INDEX PROCEDURE, REVASCULARIZATION OF THE LAD WAS DONE WITH IMPLANTATION OF A 2.5X18MM CYPHER RX STENT. SIXTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION OF THE MID AND DISTAL LAD WITH IMPLANTATION OF A NON-CORDIS STENT. MID SEGMENT PROXIMAL TO DIAGONAL TAKEOFF SHOWED AN 99% STENOSIS AND MORE DISTALLY THE VESSEL SHOWED 50% IN STENT RESTENOSIS. THE MID VESSEL DISTAL TO THE STENT SHOWED DIFFUSE 60% STENOSIS AND DISTALLY THERE IS A 75% STENOSIS AT A BEGINNING OF THE DISTAL STENTS. THE DISTAL STENT SHOWED A PROXIMAL 60% STENOSIS A MID 75% STENOSIS AND DISTAL 75% STENOSIS. THE APICAL VESSEL SHOWED PROXIMAL 75% STENOSIS. THE PATIENT WAS COMPLIANT WITH ANTIPLATELET THERAPY, HOWEVER THE PATIENT'S PLAVIX ASSAY SHOWED LOW NORMAL INHIBITION WHICH IS UNACCEPTABLE FOR EFFECTIVE TREATMENT; THEREFORE, EFFIENT WAS PRESCRIBED. 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 AND VESSEL/LESION 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.
THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00057, 3003742446-2011-00058, AND 3003742446-2011-00416.
ADDENDUM: ADDITIONAL INFORMATION WAS RECEIVED REGARDING (B)(6) 2011 PROCEDURE THROUGH CEC ADJUDICATION MINUTES. MINUTES INDICATED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT SUCCESSFUL TREATMENT WITH CUTTING BALLOON ANGIOPLASTY AND THROMBECTOMY IN THE DISTAL LAD. ADDITIONALLY, THE PATIENT UNDERWENT PLACEMENT OF 6 UNKNOWN STENTS. A FIRST STENT WAS PLACED IN THE MID VESSEL. A SECOND STENT WAS PLACED IN AN OVERLAPPING FASHION WITH THE OLD PROXIMAL AND DISTAL STENTS IN THE LAD. A THIRD AND FOURTH STENTS WERE PLACED IN THE DLAD. A FIFTH AND SIXTH STENTS WERE PLACED IN THE APICAL SEGMENT THAT OVERLAPPED WITH A PRIOR STENT. IT IS UNKNOWN HOW MANY STENTS WERE DIAGNOSED WITH A THROMBOSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00058, 3003742446-2011-00057, AND 3003742446-2011-00416.
THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00057, 3003742446-2011-00058, AND 3003742446-2011-00416. ADDITIONAL INFORMATION WAS RECEIVED.
THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00057 AND 3003742446-2011-00058. 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. REVIEW OF LOTS 15030621 AND 15034753 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.
ADDITIONAL INFORMATION WAS RECEIVED STATING SIXTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION WITH UNKNOWN DRUG-ELUTING STENT PLACEMENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS RELATED TO CORDIS PRODUCT.
THE DRUG ELUTING STENT IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY ON (B)(6) 2011 WAS NOT CORDIS PRODUCT. THIS STENT WAS WITHIN 5MM OF THE 2.5X18MM CYPHER STENT. IT WAS REPORTED THE MID SEGMENT PROXIMAL TO DIAGONAL TAKEOFF SHOWED A 99% STENOSIS AND MORE DISTALLY THE VESSEL SHOWED 50% IN-STENT RESTENOSIS. THE MID VESSEL DISTAL TO THE STENT SHOWED DIFFUSE 60% STENOSIS AND DISTALLY THERE WAS A 75% STENOSIS AT A BEGINNING OF THE DISTAL STENTS. THE DISTAL STENT SHOWED A PROXIMAL 60% STENOSIS, A MID 75% STENOSIS, AND DISTAL 75% STENOSIS. THE APICAL VESSEL SHOWED PROXIMAL 75% STENOSIS. THE PATIENT WAS COMPLIANT WITH ANTIPLATELET THERAPY; HOWEVER, THE PATIENT'S PLAVIX ASSAY SHOWED LOW NORMAL INHIBITION WHICH WAS UNACCEPTABLE FOR EFFECTIVE TREATMENT. THE PATIENT WAS STABLE WITHOUT COMPLAINTS AND CURRENTLY ON ASPIRIN AND EFFIENT.
ADDITIONAL INFORMATION WAS RECEIVED STATING THE REVASCULARIZATION OF THE MID LEFT ANTERIOR DESCENDING (LAD) WAS PERFORMED WITH A 2.5X18MM CYPHER RX STENT. THE 2.5X18MM CYPHER RX STENT WAS IMPLANTED WITHIN 5MM OF THE CYPHER RX STENT IMPLANTED DURING THE INDEX PROCEDURE. THERE WAS ALSO A RESTENOSIS OF THE CYPHER RX STENT IMPLANTED IN THE DISTAL LAD. THERE WAS NO POSSIBILITY OF DISSECTION DURING THE INDEX PROCEDURE AND NO DISTAL DISEASE WAS LEFT UNTREATED DURING THE INDEX PROCEDURE. PRE AND POST PROCEDURE TIMI FLOW FOR THE MID AND DISTAL LAD WAS 3. CORDIS PRODUCT WAS NOT USED FOR POST-DILATION. "HEALTHY TISSUE TO HEALTHY TISSUE" WAS COVERED BY THE STENTS DURING THE INDEX PROCEDURE. THE PATIENT WAS COMPLIANT WITH ANTI-PLATELET THERAPY. THE CURRENT STATUS OF THE PATIENT WAS STABLE.
AS REPORTED BY THE (B)(4) STUDY, THE PATIENT UNDERWENT REVASCULARIZATION WITH UNKNOWN DRUG-ELUTING STENT PLACEMENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY TEN MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESIONS WERE LOCATED IN THE MID LAD AND DISTAL LAD. THE LESION IN THE MID LAD WAS DESCRIBED AS 60% STENOSED, DE NOVO, NON-THROMBOSED, 18MM IN LENGTH, TYPE A, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3X10MM DURASTAR PTCA BALLOON CATHETER AT 22ATMS. A 3.5X18MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 16ATMS. THE LESION WAS POST-DILATED WITH AN UNKNOWN 3X10MM BALLOON CATHETER AT 24ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WERE NOT PROVIDED. THE LESION IN THE DISTAL LAD WAS DESCRIBED AS 75% STENOSED, DE NOVO, NON-THROMBOSED, 18MM IN LENGTH, TYPE A, WITH MODERATE CALCIFICATION. THE REFERENCE VESSEL WAS 3MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 2X15MM DURASTAR PTCA BALLOON CATHETER AT 14ATMS. A 2.5X28MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 10ATMS. THE LESION WAS POST-DILATED WITH A 2X12MM UNKNOWN BALLOON CATHETER AT 10ATMS. RESIDUAL STENOSIS WAS 0%. NO DISSECTION OCCURRED DURING THE PROCEDURE. PRE AND POST-PROCEDURE TIMI FLOW WERE NOT PROVIDED. APPROXIMATELY TEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION WITH UNKNOWN DRUG-ELUTING STENT PLACEMENT IN THE MID LAD. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE.
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 | 15030621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |