CYPHER SIROLIMUS-ELUTING CORONARY STENT

Report

Report Number: 3003742446-2013-00033
Event Type: Injury
Date Received: February 11, 2013
Date of Event: January 17, 2013
Report Date: January 18, 2013
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

Additional Manufacturer Narrative · 1

ADDENDUM ((B)(4) 2013): ADDITIONAL INFORMATION IN THE REVISED CRF REGARDING (B)(4) 2013 PROCEDURE INDICATED THAT THE PATIENT WAS BROUGHT IN FOR ELECTIVE ANGIO. THE LEFT CIRCUMFLEX WAS NEARLY OCCLUDED AT 90% WITH STENT IN MID. A 3.0 X 15 TREK BALLOON DEPLOYED FOR 30 SECONDS. AND THE INSTENT RESTENOSIS WAS DECREASED TO 30% WITH TIMI 3 FLOW. THIS NEW INFORMATION DOES NOT CHANGE ANY CRITERIA OF THIS FILE AS THE CODE FOR REOCCLUSION HAD PREVIOUSLY BEEN REPORTED AT THE TIME OF INITIAL REPORT. THIS IS JUST TO UPDATE ABOVE ADDITIONAL INFORMATION AS RECEIVED FROM THE SITE. UPDATED COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT EXPERIENCED CORONARY ARTERY RESTENOSIS. THE PATIENT WAS ENROLLED IN THE STUDY WITH A MEDICAL HISTORY OF ANGINA, HISTORY OF PREVIOUS PCI - (B)(6)2004, FAMILY HISTORY OF CORONARY ARTERY DISEASE (CAD), HISTORY OF HYPERTENSION, HISTORY OF MYOCARDIAL INFARCTION, HISTORY OF DIABETES MELLITUS, AND SMOKING. AT THE TIME OF INDEX PROCEDURE, THE DISTAL CIRCUMFLEX TARGET LESION WAS REPORTED TO BE: DE NOVO, AN 85% STENOSIS, 2.75 MM REFERENCE DIAMETER, 12 MM LENGTH, MILDLY CALCIFIED, NOT TORTUOUS, ABSENT OF THROMBUS, AND TYPE B1. THE LESION WAS PRE-DILATED WITH A FIRESTAR 2.75 X 15 MM BALLOON CATHETER AT 14 ATM. A CYPHER 2.75 X 18 MM STENT WAS IMPLANTED AT 16 ATM. THE STENT WAS NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS OR DEVICE DEVIATIONS. APPROXIMATELY 32 MONTHS POST INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION OF AN UNKNOWN VESSEL. EVENT RESOLVED WITHOUT SEQUELAE. ADDITIONAL INFORMATION IN THE REVISED CRF REGARDING (B)(6) 2013 PROCEDURE INDICATED THAT A PATIENT HAD UNDERGONE TREATMENT OF TARGET LESION DISTAL CX THAT WAS PREVIOUSLY UNKNOWN. ADDITIONAL INFORMATION IN THE REVISED CRF REGARDING (B)(6) 2013 PROCEDURE INDICATED THAT THE PATIENT WAS BROUGHT IN FOR ELECTIVE ANGIO. THE LEFT CIRCUMFLEX WAS NEARLY OCCLUDED AT 90% WITH STENT IN MID. A 3.0 X 15 TREK BALLOON DEPLOYED FOR 30 SECONDS. AND THE INSTENT RESTENOSIS WAS DECREASED TO 30% WITH TIMI 3 FLOW. THE STUDY STENT REMAIN IMPLANTED THUS UNAVAILABLE 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 LOT 15109747 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH 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 INSTENT 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, CAD, AND SMOKING.

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICATIONS INCLUDED HMG COA REDUCTASE INHIBITORS AND BETA BLOCKING AGENTS. THE REPORT RECEIVED FROM THE CYPRESS STUDY INDICATED THAT THE PATIENT EXPERIENCED CORONARY ARTERY RESTENOSIS. THE PATIENT WAS ENROLLED IN THE STUDY WITH A MEDICAL HISTORY OF ANGINA, HISTORY OF PREVIOUS PCI-(B)(6) 2004, FAMILY HISTORY OF CORONARY ARTERY DISEASE (CAD), HISTORY OF HYPERTENSION, HISTORY OF MYOCARDIAL INFARCTION, HISTORY OF DIABETES MELLITUS, AND SMOKING. AT THE TIME OF INDEX PROCEDURE, THE DISTAL CIRCUMFLEX TARGET LESION WAS REPORTED TO BE: DE NOVO, AN 85% STENOSIS, 2.75 MM REFERENCE DIAMETER, 12 MM LENGTH, MILDLY CALCIFIED, NOT TORTUOUS, ABSENT OF THROMBUS, AND TYPE B1. THE LESION WAS PRE-DILATED WITH A FIRESTAR 2.75 X 15 MM BALLOON CATHETER AT 14 ATM. A CYPHER 2.75 X 18 MM STENT WAS IMPLANTED AT 16 ATM. THE STENT WAS NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS OR DEVICE DEVIATIONS. APPROXIMATELY 32 MONTHS POST INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION OF AN UNKNOWN VESSEL. EVENT RESOLVED WITHOUT SEQUELAE. ADD INFO HAS BEEN ORDERED. THE STUDY STENT REMAIN IMPLANTED THUS UNAVAILABLE 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 LOT 15109747 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH 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 INSTENT 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, CAD, AND SMOKING.

Additional Manufacturer Narrative · 1

ADDENDUM ((B)(4) 2013): ADDITIONAL INFORMATION IN THE REVISED CRF REGARDING (B)(6) 2013 PROCEDURE INDICATED THAT A PATIENT HAD UNDERGONE TREATMENT OF TARGET LESION DISTAL CX THAT WAS PREVIOUSLY UNKNOWN. PLEASE NOTE THAT THIS NEW INFO DOES NOT CHANGE ANY REPORTABILITY/DETERMINATION OF THIS FILE AS THE CODE FOR REOCCLUSION HAD ALREADY BEEN REPORTED AT THE TIME OF INITIAL REPORT. UPDATED COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE CYPRESS STUDY INDICATED THAT THE PATIENT EXPERIENCED CORONARY ARTERY RESTENOSIS. THE PATIENT WAS ENROLLED IN THE STUDY WITH A MEDICAL HISTORY OF ANGINA, HISTORY OF PREVIOUS (B)(4), FAMILY HISTORY OF CORONARY ARTERY DISEASE (CAD), HISTORY OF HYPERTENSION, HISTORY OF MYOCARDIAL INFARCTION, HISTORY OF DIABETES MELLITUS, AND SMOKING. AT THE TIME OF INDEX PROCEDURE, THE DISTAL CIRCUMFLEX TARGET LESION WAS REPORTED TO BE: DE NOVO, AN 85% STENOSIS, 2.75 MM REFERENCE DIAMETER, 12 MM LENGTH, MILDLY CALCIFIED, NOT TORTUOUS, ABSENT OF THROMBUS, AND TYPE B1. THE LESION WAS PRE-DILATED WITH A FIRESTAR 2.75 X 15 MM BALLOON CATHETER AT 14 ATM. A CYPHER 2.75 X 18 MM STENT WAS IMPLANTED AT 16 ATM. THE STENT WAS NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS OR DEVICE DEVIATIONS. APPROXIMATELY 32 MONTHS POST INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION OF AN UNKNOWN VESSEL. EVENT RESOLVED WITHOUT SEQUELAE. ADDITIONAL INFORMATION IN THE REVISED CRF REGARDING (B)(6) 2013 PROCEDURE INDICATED THAT A PATIENT HAD UNDERGONE TREATMENT OF TARGET LESION DISTAL CX THAT WAS PREVIOUSLY UNKNOWN. THE STUDY STENT REMAIN IMPLANTED THUS UNAVAILABLE 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 LOT 15109747 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH 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 INSTENT 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, CAD, AND SMOKING.

Description of Event or Problem · 1

THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT EXPERIENCED CORONARY ARTERY RESTENOSIS. THE PATIENT WAS ENROLLED IN THE STUDY WITH A MEDICAL HISTORY OF ANGINA, HISTORY OF PREVIOUS PCI-(B)(6) 2004, FAMILY HISTORY OF CORONARY ARTERY DISEASE (CAD), HISTORY OF HYPERTENSION, HISTORY OF MYOCARDIAL INFARCTION, HISTORY OF DIABETES MELLITUS, AND SMOKING. AT THE TIME OF INDEX PROCEDURE, THE DISTAL CIRCUMFLEX TARGET LESION WAS REPORTED TO BE: DE NOVO, AN 85% STENOSIS, 2.75 MM REFERENCE DIAMETER, 12 MM LENGTH, MILDLY CALCIFIED, NOT TORTUOUS, ABSENT OF THROMBUS, AND TYPE B1. THE LESION WAS PRE-DILATED WITH A FIRESTAR 2.75 X 15 MM BALLOON CATHETER AT 14 ATM. A CYPHER 2.75 X 18 MM STENT WAS IMPLANTED AT 16 ATM. THE STENT WAS NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS OR DEVICE DEVIATIONS. APPROXIMATELY 32 MONTHS POST INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION OF AN UNKNOWN VESSEL. EVENT RESOLVED WITHOUT SEQUELAE. ADD INFO HAS BEEN ORDERED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
58247	CYPHER SIROLIMUS-ELUTING CORONARY STENT	DRUG-ELUTING STENT (NIQ)	NIQ	CORDIS LLC (PR)	NA	15109747

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Hospitalization\| R