CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00215
- Event Type
- Injury
- Date Received
- April 29, 2011
- Date of Event
- April 29, 2011
- Report Date
- April 5, 2011
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00214, 3003742446-2011-00215, AND 3003742446-2011-00216. AS REPORTED BY THE (B)(4) STUDY, ONE YEAR AFTER THE INDEX PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS OF THE CYPHER STENTS IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT ALSO EXPERIENCED IN-STENT RESTENOSIS OF UNKNOWN STENTS IMPLANTED IN THE PROXIMAL AND DISTAL CIRCUMFLEX (CX). THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, PREVIOUS CORONARY INTERVENTION WITH UNKNOWN DRUG-ELUTING STENT IMPLANTATION, HYPERLIPIDEMIA, HYPERTENSION, CEREBRAL VASCULAR ACCIDENT/STROKE, MYOCARDIAL INFARCTION, DIABETES, AN ALLERGY TO SULFA, AND KIDNEY STONES. THE TARGET LESION WAS LOCATED IN THE DISTAL LAD. THE NON-TARGET LESIONS WERE LOCATED IN THE PROXIMAL LAD, MID LAD, AND FIRST OBTUSE MARGINAL. THE LESION IN THE DISTAL LAD WAS DESCRIBED AS 98% STENOSED, 65MM IN LENGTH, TYPE B1, NON-THROMBOSED, DE NOVO, AND WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER AND NON-TORTUOUS. THE FIRST 2.25X23MM CYPHER RX STENT WAS IMPLANTED AT 14ATMS. THE SECOND 2.5X28MM CYPHER RX STENT WAS IMPLANTED OVERLAPPING THE INITIAL STENT AT 20ATMS. THE THIRD 2.5X28MM CYPHER RX STENT WAS IMPLANTED OVERLAPPING THE INITIAL STENT AT 18ATMS. THE CYPHER RX STENTS WERE ALL PRE AND POST-DILATED. RESIDUAL STENOSIS WAS 10%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. THE NON-TARGET LESION IN THE MID LAD WAS DESCRIBED AS AN IN-STENT RESTENOSIS OF AN UNKNOWN DRUG-ELUTING STENT. THE LESION WAS 12MM IN LENGTH. A 3.0X15MM XIENCE STENT WAS IMPLANTED AT 14ATMS. RESIDUAL STENOSIS WAS 10% AND POST-PROCEDURE TIMI FLOW WAS 3. THE NON-TARGET LESION IN THE PROXIMAL LAD WAS DESCRIBED AS 15MM IN LENGTH AND DE NOVO. A 3X18MM XIENCE STENT WAS IMPLANTED AT 14ATMS. RESIDUAL STENOSIS WAS 10% AND POST-PROCEDURE TIMI FLOW WAS 3. THE NON-TARGET LESION IN THE FIRST OBTUSE MARGINAL WAS DESCRIBED AS 24MM IN LENGTH AND DE NOVO. A 3X28MM XIENCE STENT WAS IMPLANTED AT 12ATMS. RESIDUAL STENOSIS WAS 10% AND POST-PROCEDURE TIMI FLOW WAS 3. AT THE 12MONTH FOLLOW-UP VISIT, THE PATIENT EXPERIENCED STABLE ANGINA. ANGIOGRAPHY WAS PERFORMED AND THE PATIENT UNDERWENT REVASCULARIZATION OF THE DISTAL LAD, MID LAD, PROXIMAL LAD, PROXIMAL CX, AND DISTAL CX DUE TO IN-STENT RESTENOSIS. THE EVENTS WERE TREATED WITH THE IMPLANT OF CYPHER STENTS IN THE PROXIMAL, MID AND DISTAL LAD, AND THE PROXIMAL AND DISTAL CFX. THE LOT AND CATALOG NUMBERS FOR THE TREATMENT STENTS ARE UNKNOWN. 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. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY RESTENOSIS AND IS MOST PREVALENT IN LONG LESIONS, LESIONS THAT ARE RESTENOSED AND IN PATIENTS WITH DIABETES AND HYPERTENSION. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT LESION CHARACTERISTICS AND/OR PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INDICATION THAT THERE IS A DESIGN OF MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED.
THIS IS ONE OF FIVE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00214, 3003742446-2011-00215, 3003742446-2011-00216, AND 3003742446-2011-00350, AND 3003742446-2011-00351.
THIS IS ONE OF FIVE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00214, 3003742446-2011-00215, 3003742446-2011-00216, AND 3003742446-2011-00350, AND 3003742446-2011-00351. (B)(4) - 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 15120203 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) - 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 15096316 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) - 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 15096316 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.
THE PRODUCTS ARE NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00214, 3003742446-2011-00215, AND 3003742446-2011-00216. THE EVENTS RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE REVASCULARIZATION OF THE DISTAL LAD WAS RELATED TO CORDIS PRODUCT. ACCORDING TO THE INVESTIGATOR, THE REVASCULARIZATION OF THE MID LAD, PROXIMAL LAD, PROXIMAL CX, AND DISTAL CX WAS NOT RELATED TO CORDIS PRODUCT. THE EVENTS RESOLVED WITHOUT SEQUELAE. THE STUDY COORDINATOR STATED THAT THE PREVIOUSLY IMPLANTED STENTS IN THE MID LAD, PROXIMAL CIRCUMFLEX (CX), AND DISTAL CX WAS UNKNOWN. ALL THREE CYPHER RX STENTS IMPLANTED IN THE DISTAL LAD HAD RESTENOSIS AND WERE TREATED (ON (B)(6) 2011) WITH CYPHER STENTS. SHE STATED THE LOT NUMBER AND CATALOG NUMBER WAS UNKNOWN. SHE ALSO CONFIRMED THE LESIONS IN THE MID LAD, PROXIMAL LAD, PROXIMAL CX, AND DISTAL CX WERE TREATED (ON (B)(6) 2011) WITH CYPHER STENTS. THE LOT NUMBER AND CATALOG NUMBER WAS UNKNOWN.
(B)(4) CEC ADJUDICATION MINUTES WERE RECEIVED ON 8-10-2011 AND THE COMMITTEE AGREED WITH THE ASSESSMENT OF TARGET LESION, PERCUTANEOUS INTERVENTION- CLINICALLY DRIVEN, RELATED TO DEVICE. THE COMMITTEE WAS ALSO IN AGREEMENT WITH TARGET VESSEL, PERCUTANEOUS INTERVENTION- CLINICALLY DRIVEN. THESE EVENTS HAVE ALREADY BEEN CAPTURED AND REPORTED. THE STUDY COORDINATOR ORIGINALLY INDICATED THAT THE EVENTS WERE TREATED WITH THE IMPLANT OF CYPHER STENTS ON (B)(6) 2011. HOWEVER, THE CEC MINUTES INDICATED THAT THE EVENTS WERE TREATED WITH NON-CORDIS STENTS (IMPLANTED ON (B)(6) 2011) THAT WERE LOCATED FROM THE DISTAL, ALMOST NEAR THE APEX, LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY TO THE PROXIMAL LAD. THE STUDY COORDINATOR CLARIFIED THAT THE RESTENOSIS THAT OCCURRED ON (B)(6) 2011 WAS TREATED WITH NON-CORDIS STENTS. THE PATIENT EXPERIENCED SUB-ACUTE STENT THROMBOSIS AND ACUTE ST ELEVATION MYOCARDIAL INFARCTION ON (B)(6) 2011 AND TREATMENT INCLUDED THROMBECTOMY AND PTCA ONLY. NO NEW STENTS WERE IMPLANTED. THE MEDICATIONS USED FOR TREATMENT INCLUDED PLAVIX, LEVENOX, AND INTRAVENOUS HEPARIN AND REOPRO. ADJUDICATION MINUTES CONFIRMED THAT IVUS POST-TREATMENT CONFIRMED THE STENTS STRUTS WERE WELL APPOSED AND THERE WAS NO RESIDUAL THROMBUS.
AS REPORTED BY THE (B)(4) STUDY, ONE YEAR AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS OF THE CYPHER STENTS IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT ALSO EXPERIENCED IN-STENT RESTENOSIS OF UNKNOWN STENTS IMPLANTED IN THE PROXIMAL AND DISTAL CIRCUMFLEX (CX). THE TARGET LESION WAS LOCATED IN THE DISTAL LAD. THE NON-TARGET LESIONS WERE LOCATED IN THE PROXIMAL LAD, MID LAD, AND FIRST OBTUSE MARGINAL. THE LESION IN THE DISTAL LAD WAS DESCRIBED AS 98% STENOSED, 65MM IN LENGTH, TYPE B1, NON-THROMBOSED, DE NOVO, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER AND NON-TORTUOUS. THE FIRST 2.25X23MM CYPHER RX STENT WAS IMPLANTED AT 14ATMS. THE SECOND 2.5X28MM CYPHER RX STENT WAS IMPLANTED OVERLAPPING THE INITIAL STENT AT 20ATMS. THE THIRD 2.5X28MM CYPHER RX STENT WAS IMPLANTED OVERLAPPING THE INITIAL STENT AT 18ATMS. THE CYPHER RX STENTS WERE ALL PRE AND POST-DILATED. RESIDUAL STENOSIS WAS 10%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. THE NON-TARGET LESION IN THE MID LAD WAS DESCRIBED AS AN IN-STENT RESTENOSIS OF AN UNKNOWN DRUG-ELUTING STENT. THE LESION WAS 12MM IN LENGTH. A 3.0X15MM XIENCE STENT WAS IMPLANTED AT 14ATMS. RESIDUAL STENOSIS WAS 10% AND POST-PROCEDURE TIMI FLOW WAS 3. THE NON-TARGET LESION IN THE PROXIMAL LAD WAS DESCRIBED AS 15MM IN LENGTH AND DE NOVO. A 3X18MM XIENCE STENT WAS IMPLANTED AT 14ATMS. RESIDUAL STENOSIS WAS 10% AND POST-PROCEDURE TIMI FLOW WAS 3. THE NON-TARGET LESION IN THE FIRST OBTUSE MARGINAL WAS DESCRIBED AS 24MM IN LENGTH AND DE NOVO. A 3X28MM XIENCE STENT WAS IMPLANTED AT 12ATMS. RESIDUAL STENOSIS WAS 10% AND POST-PROCEDURE TIMI FLOW WAS 3. AT THE 12MONTH FOLLOW-UP VISIT, THE PATIENT EXPERIENCED STABLE ANGINA. THE PATIENT UNDERWENT REVASCULARIZATION OF THE DISTAL LAD, MID LAD, PROXIMAL LAD, PROXIMAL CX, AND DISTAL CX DUE TO IN-STENT RESTENOSIS. TREATMENT INCLUDED IMPLANTATION OF UNKNOWN DRUG-ELUTING STENTS.
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 | 15096316 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |