CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00296
- Event Type
- Injury
- Date Received
- June 10, 2011
- Date of Event
- April 28, 2010
- Report Date
- May 16, 2011
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT DEVICES: CXS13250 (LOT 15115514) AND CXS13300 (LOT 15111511). CONCOMITANT MEDICATIONS: PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ALTACE, ASPIRIN AND LIPITOR. INTRA-PROCEDURE MEDICATIONS INCLUDED BIVALIRUDIN. POST-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL, PRASUGREL, ALTACE, ASPIRIN AND LIPITOR. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURER NUMBERS 3003742446-2011-00296, 3003742446-2011-00297 AND 3003742446-2011-00298.
THE COMPLAINT RECEIVED STATES THAT PRE INDEX PROCEDURE, THIS (B)(4) STUDY PATIENT SUFFERED ARRHYTHMIA. THIS IS A (B)(6) MALE PATIENT WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF PREVIOUS PCI ((B)(6) 2002), PROSTATE CANCER ((B)(6) 2008) AND PAST SMOKER. THE PATIENT WAS ADMITTED TO THE FACILITY TWO DAYS PRIOR TO THE INDEX PROCEDURE WITH NON-ST SEGMENT ELEVATION ACS (ACUTE CORONARY SYNDROME) WITH POSITIVE ENZYMES INDICATING AN MI. THE TARGET LESION WAS 1ST DIAGONAL, SITE PREVIOUSLY TREATED WITH POBA IN 2002, DESCRIBES AS TIMI FLOW 0, 100% OCCLUDED WITH THROMBOSIS, OSTIAL TYPE B1. PRE-DILATION WAS PERFORMED AND A 2.5X18MM CYPHER STENT WAS DEPLOYED AT 14 ATMS. POST-DILATION WAS PERFORMED; RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. THE SECOND TARGET LESION WAS 2ND OM DESCRIBED AS DE NOVO, 90% WITH MILD TORTUOUSITY, TYPE A. A 2.5X13MM CYPHER STENT WAS DEPLOYED AT 14 ATM. POST-DILATION WAS PERFORMED. A THIRD TARGET LESION, ALSO LOCATED ON 2ND OM, HOWEVER PROXIMAL AND TO THE TARGET LESION #2, HAD A 3.0X13MM CYPHER STENT IMPLANTED. POST-DILATION WAS PERFORMED AND RESIDUAL STENOSIS WAS 0% AND TIMI FLOW 3 WAS NOTED. IT WAS REPORTED THAT TWO DAYS PRIOR TO PROCEDURE THE PATIENT HAD EXPERIENCED NON-SUSTAINED VT THAT WAS TREATED WITH AMIODARONE. THE RELATIONSHIP WAS DESCRIBED AS NONE TO THE PROCEDURE AND THE DEVICES. 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 15109748 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ARRHYTHMIA IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION. PENDING DHR REVIEW, THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. ARRHYTHMIA IS ALSO ASSOCIATED WITH ACUTE MI, IN THIS CASE THE PATIENT WAS ADMITTED WITH AN ACUTE MI SITUATION AND THE REPORTED EVENT OCCURRED PRIOR TO THE INSERTION OF THE CORONARY STENTS. THIS IS ONE OF THREE DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURER NUMBERS 3003742446-2011-00296, 3003742446-2011-00297 AND 3003742446-2011-00298.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE THAT THE VENTRICULAR TACHYCARDIA OCCURRED AFTER IMPLANTATION OF THE FIRST STENT AND THE CONCLUSION WAS REVISED ACCORDINGLY. THERE WERE NO CHANGES TO THE PREVIOUSLY PROVIDED EVALUATION CODES. THE COMPLAINT RECEIVED STATES THAT DURING THE INDEX PROCEDURE THIS CYPRESS STUDY PATIENT SUFFERED ARRHYTHMIA. THIS IS A (B)(6) MALE PATIENT WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF PREVIOUS PCI ((B)(6) 2002), PROSTATE CANCER ((B)(6) 2008) AND PAST SMOKER. THE PATIENT WAS ADMITTED TO THE FACILITY TWO DAYS PRIOR TO THE INDEX PROCEDURE WITH NON-ST SEGMENT ELEVATION ACS (ACUTE CORONARY SYNDROME) WITH POSITIVE ENZYMES INDICATING AN MI. THE TARGET LESION WAS 1ST DIAGONAL, SITE PREVIOUSLY TREATED WITH POBA IN 2002, DESCRIBES AS TIMI FLOW 0, 100% OCCLUDED WITH THROMBOSIS, OSTIAL TYPE B1. PRE-DILATION WAS PERFORMED AND A 2.5X18MM CYPHER STENT WAS DEPLOYED AT 14 ATMS. POST-DILATION WAS PERFORMED; RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. THE SECOND TARGET LESION WAS 2ND OM DESCRIBED AS DE NOVO, 90% WITH MILD TORTUOUSITY, TYPE A. A 2.5X13MM CYPHER STENT WAS DEPLOYED AT 14 ATM. POST-DILATION WAS PERFORMED. A THIRD TARGET LESION, ALSO LOCATED ON 2ND OM, HOWEVER PROXIMAL AND TO THE TARGET LESION #2, HAD A 3.0X13MM CYPHER STENT IMPLANTED. POST-DILATION WAS PERFORMED AND RESIDUAL STENOSIS WAS 0% AND TIMI FLOW 3 WAS NOTED. AFTER THE INSERTION OF THE FIRST STENT THE PATIENT HAD AN EPISODE OF NON-SUSTAINED VT (VENTRICULAR TACHYCARDIA). THE NON-SUSTAINED VT THAT WAS TREATED WITH AN IV INFUSION OF AMIODARONE SUCCESSFULLY. THE RELATIONSHIP WAS DESCRIBED AS NONE TO THE PROCEDURE AND THE DEVICES. 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 15109748 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ARRHYTHMIA IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION. PENDING DHR REVIEW, THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. ARRHYTHMIA IS ALSO ASSOCIATED WITH ACUTE MI, IN THIS CASE THE PATIENT WAS ADMITTED WITH AN ACUTE MI SITUATION AND THE REPORTED EVENT OCCURRED PRIOR TO THE INSERTION OF THE CORONARY STENTS. THIS IS ONE OF THREE DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2011-00296, 3003742446-2011-00297 AND 3003742446-2011-00298.
THE EMAIL RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT HAS A HISTORY OF NON SUSTAINED VT WITH NO RELATIONSHIP TO PROCEDURE OR STENT. IT WAS TREATED WITH AMIODARONE. THE PATIENT WAS ADMITTED UNDER NON-ST SEGMENT ELEVATION ACUTE CORONARY SYNDROME SETTING WITH AN MI 2 DAYS PRIOR TO THE PROCEDURE AND THE CARDIAC ENZYMES WERE ELEVATED PRE-AND POST PROCEDURE. PCI WAS PERFORMED ON A LESION PREVIOUSLY TREATED WITH BALLOON ANGIOPLASTY ON (B)(6) 2002. PCI WAS FIRST PERFORMED ON A 100% DE NOVO LESION IN THE 1ST DIAGONAL OF 10MM IN LENGTH IN A 3.0MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOUSITY. THE (B1) LESION WAS OSTIAL, ARTERIAL VESSEL TYPE, DEFINITE THROMBOSIS PRESENT IN THE VESSEL AND TIMI 0 FLOW. A 2.5X18MM CYPHER STENT WAS DEPLOYED AT 14 ATM. POST-DILATATION WAS PERFORMED WITH A 2.5X10MM DURASTAR BALLOON AT 20 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0% AND TIMI 3 FLOW WAS RESTORED. PCI WAS PERFORMED NEXT ON A 90% DE NOVO LESION IN THE 2ND OM OF 8MM IN LENGTH IN A 2.5MM VESSEL DIAMETER WITH MILD VESSEL TORTUOUSITY. THE (TYPE A) LESION WAS ARTERIAL. A 2.5X13MM CYPHER STENT WAS DEPLOYED AT 14 ATM. POST-DILATATION WAS PERFORMED WITH A 2.5X10MM DURASTAR BALLOON AT 10 ATM. FOLLOWED BY A 3.0X13MM CYPHER, SEPARATE FROM THE PREVIOUS STENT IS A DIFFERENT LESION IN THE SAME VESSEL, PROXIMAL TO THE PREVIOUS STENT. POST-DILATATION WAS PERFORMED WITH A 235X15MM DURASTAR BALLOON AT 6 ATM. TIMI 3 FLOWS WERE RECORDED PRE AND POST-PROCEDURE. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%.
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 | 15109748 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |