CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00303
- Event Type
- Injury
- Date Received
- June 14, 2011
- Date of Event
- August 8, 2011
- Report Date
- June 13, 2012
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 3003742446-2011-00303 AND 3003742446-2011-00304.
PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2011-00303 AND 3003742446-2011-00304. UPDATED COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) PATIENT UNDERWENT CORONARY STENT PLACEMENT HAD ELEVATED ENZYMES POST PROCEDURE AND SUFFERED INSTENT RESTENOSIS APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE. THE PATIENT IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING ANGINA, CABG 1987, STABLE ANGINA PECTORIS, HYPERLIPIDEMIA, HYPERTENSION, SMOKER, PROSTRATE CANCER 2002, ACUTE CORONARY SYNDROME, GASTROESOPHAGEAL REFLUX DISEASE, AUTOIMMUNE DISEASE. ON (B)(6), 2010 THE PATIENT UNDERWENT SUCCESSFUL ANGIOPLASTY AND STENTING OF THE RIGHT CORONARY ARTERY (RCA) WITH TWO CYPHER ((B)(4)/ LOT 15099041 AND (B)(4)/ LOT 15111599) STENTS IMPLANTED IN THE MID AND DISTAL RCA. THE PROCEDURE WENT WELL AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT WAS DISCHARGED THE NEXT DAY. IT WAS NOTED THAT POST PROCEDURE THE PATIENT TROPONIN LEVELS WERE ELEVATED. THE EVENT WAS EVALUATED AND DETERMINED TO BE POSSIBLY RELATED TO THE INDEX PROCEDURE AND CORDIS STENT. NO TREATMENT WAS GIVEN. APPROXIMATELY A YEAR AND FOUR MONTHS POST INDEX PROCEDURE THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT DOCUMENTED, HOWEVER ADDITIONAL INFORMATION STATES THAT THE MEDICAL RECORD INDICATES PULSE LESS ELECTRICAL ACTIVITY ARREST AS THE CAUSE OF DEATH. THE EVENT RELATIONSHIP TO DEVICE IS UNKNOWN. TO DATE NO FURTHER INFORMATION HAS BEEN AVAILABLE. THE STUDY STENTS 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 15099041 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ELEVATED CARDIAC ENZYMES ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. 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. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND SMOKING. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CORONARY STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT WAS OF ADVANCED AGE AND HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH.
(B)(4) ADJUDICATION MINUTES RECEIVED INDICATED THAT THE PATIENT EXPERIENCED MI APPROXIMATELY SIXTEEN MONTHS AFTER THE INDEX PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR PRE-OPERATIVE EVALUATION FOR A REDO CABG SURGERY, WHICH WAS PLANNED ONE AND HALF WEEK LATER. THE PATIENT WAS ASYMPTOMATIC AT THAT TIME, BUT REFERRED TO INCREASED ASTHENIA OVER THE PREVIOUS FEW DAYS WITH NO COMPLAINTS OF CHEST PAIN OR SHORTNESS OF BREATH. THE SITE REPORTED THAT THE ECG REVEALED A COMPLETE HEART BLOCK. THE CKMB WAS 3.6 (NL 3.6) AND THE TROPONIN I WAS 0.288 (NL 0.045). THE ECG CORE LAB REPORTED PERSISTENT THIRD DEGREE AV BLOCK AND UNINTERPRETABLE MI DUE TO VENTRICULAR ESCAPE RHYTHM. THE PATIENT WAS TRANSFERRED TO THE CATHETERIZATION LAB WHERE AN INSERTION OF A TEMPORARY PACEMAKER WAS PERFORMED. AS NOTED IN THE PHYSICIAN'S SUMMARY NO SIGNIFICANT CULPRIT LESION WAS IDENTIFIED, BUT THE ELEVATION IN ENZYMES WAS DEEMED TO BE RELATED TO THE STUDY STENTS AS PER RECEIVED ADJUDICATION MINUTES. COMPLAINT CONCLUSION: PER THE (B)(4) ADJUDICATION THE PATIENT HAD ELEVATED ENZYMES POST INDEX PROCEDURE AND THEN SUFFERED RESTENOSIS AND AN MI LEADING TO DEATH, 16 MONTHS POST INDEX PROCEDURE. THE PATIENT WAS A (B)(6) MAN WITH A HISTORY OF CABG SURGERY IN 1987, CURRENT SMOKING, DYSLIPIDEMIA, PROSTATE CANCER IN 2002, AND HYPERTENSION WHO PRESENTED WITH STABLE ANGINA AND AN 80% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS ENROLLED IN THE CYPRESS STUDY. ON (B)(6) 2010, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH BALLOON ANGIOPLASTY AND PLACEMENT OF ONE STUDY (CXS33350/ LOT 1509904) STENT IN THE MID RCA AND A SECOND STENT (CXS33300/ LOT 15111599) IN THE DISTAL RCA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. POST PROCEDURE THE PATIENT'S TROPONIN L WAS ELEVATED. ON (B)(6) 2010; THE PATIENT RETURNED COMPLAINING OF ANGINA. ANGIOGRAPHY SHOWED A RESTENOSIS OF THE CYPHER STENT (CXS33350/ LOT 15099041) THAT WAS PLACED IN THE MID RCA. THE LESION WAS WITHIN 5MM OF THE CYPHER STENT IN THE DISTAL RCA AS THE STENTS WERE OVERLAPPING. THE RESTENOSIS WAS TREATED WITH A CUTTING BALLOON AND PLACEMENT OF A BARE-METAL STENT. (B)(4) ADJUDICATION MINUTES RECEIVED INDICATED THAT THE PATIENT EXPERIENCED MI APPROXIMATELY SIXTEEN MONTHS AFTER THE INDEX PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR PRE-OPERATIVE EVALUATION FOR A REDO CABG SURGERY, WHICH WAS PLANNED ONE AND HALF WEEK LATER. THE PATIENT WAS ASYMPTOMATIC AT THAT TIME, BUT REFERRED TO INCREASED ASTHENIA OVER THE PREVIOUS FEW DAYS WITH NO COMPLAINTS OF CHEST PAIN OR SHORTNESS OF BREATH. THE SITE REPORTED THAT THE ECG REVEALED A COMPLETE HEART BLOCK. THE CKMB WAS 3.6 (NL 3.6) AND THE TROPONIN I WAS 0.288 (NL 0.045). THE ECG CORE LAB REPORTED PERSISTENT THIRD DEGREE AV BLOCK AND UNINTERPRETABLE MI DUE TO VENTRICULAR ESCAPE RHYTHM. THE PATIENT WAS TRANSFERRED TO THE CATHETERIZATION LAB WHERE AN INSERTION OF A TEMPORARY PACEMAKER WAS PERFORMED. AS NOTED IN THE PHYSICIAN'S SUMMARY NO SIGNIFICANT CULPRIT LESION WAS IDENTIFIED, BUT THE ELEVATION IN ENZYMES WAS DEEMED TO BE RELATED TO THE STUDY STENTS AS PER RECEIVED ADJUDICATION MINUTES. APPROXIMATELY A YEAR AND FOUR MONTHS POST INDEX PROCEDURE THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT DOCUMENTED, HOWEVER, ADDITIONAL INFORMATION STATES THAT THE MEDICAL RECORD INDICATES PULSE LESS ELECTRICAL ACTIVITY ARREST AS THE CAUSE OF DEATH. THE EVENT RELATIONSHIP TO DEVICE IS UNKNOWN. THE CYPHER STENTS 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 15099041 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ELEVATED CARDIAC ENZYMES ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. MYOCARDIAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. 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. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. 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 IS 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 AND SMOKING. DEATH, FROM ISCHEMIC HEART DISEASE, IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CORONARY STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. 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. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2011-00303 AND 3003742446-2011-00304.
THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT UNDERWENT CORONARY STENT PLACEMENT HAD ELEVATED ENZYMES POST PROCEDURE AND SUFFERED IN-STENT RESTENOSIS APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE. THE PATIENT IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING ANGINA, CABG 1987, STABLE ANGINA PECTORIS, HYPERLIPIDEMIA, HYPERTENSION, SMOKER, PROSTRATE CANCER 2002, ACUTE CORONARY SYNDROME, GASTROESOPHAGEAL REFLUX DISEASE, (B)(6). ON (B)(6) 2010, THE PATIENT UNDERWENT SUCCESSFUL ANGIOPLASTY AND STENTING OF THE RIGHT CORONARY ARTERY (RCA) WITH TWO CYPHER (CXS33350/ LOT 15099041 AND CXS33300 / LOT 15111599) STENTS IMPLANTED IN THE MID AND DISTAL RCA. THE PROCEDURE WENT WELL AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT WAS DISCHARGED THE NEXT DAY. IT WAS NOTED THAT POST PROCEDURE, THE PATIENT TROPONIN LEVELS WERE ELEVATED. THE EVENT WAS EVALUATED AND DETERMINED TO BE POSSIBLY RELATED TO THE INDEX PROCEDURE AND CORDIS STENT. NO TREATMENT WAS GIVEN. THE PATIENT PRESENTED WITH GROSS HEMATURIA RELATED TO BLADDER CANCER THAT WAS PREVIOUSLY CAPTURED AS A NON-COMPLAINT, AND AT THE SAME TIME ISR WAS NOTED OF THE INDEX STENTS. THE STUDY STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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. ELEVATED CARDIAC ENZYMES ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. 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. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND SMOKING. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 3003742446-2011-00303 AND 3003742446-2011-00304.
THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011: APPROXIMATELY (B)(6) POST INDEX PROCEDURE THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT DOCUMENTED, HOWEVER ADDITIONAL INFORMATION STATES THAT THE MEDICAL RECORD INDICATES PULSE LESS ELECTRICAL ACTIVITY ARREST AS THE CAUSE OF DEATH. THE EVENT RELATIONSHIP TO DEVICE IS UNKNOWN. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG REPORT # 3003742446-2011-00303 AND 3003742446-2011-00304. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.
APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE, THE PATIENT WAS FOUND TO HAVE A RESTENOSIS OF THE PREVIOUSLY IMPLANTED CYPHER STENT. THE PATIENT IS A (B)(6) MAN WITH A HISTORY OF CABG SURGERY IN 1987, CURRENT SMOKING, DYSLIPIDEMIA, PROSTATE CANCER IN 2002, AND HYPERTENSION WHO PRESENTED WITH STABLE ANGINA AND AN 80% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY. ON (B)(6) 2010, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH BALLOON ANGIOPLASTY AND PLACEMENT OF ONE STUDY (CXS33350/ LOT 1509904) STENT IN THE MID RCA AND A SECOND STENT (CXS33300/ LOT 15111599) IN THE DISTAL RCA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. POST PROCEDURE THE PATIENT'S TROPONIN L WAS ELEVATED. ON (B)(6) 2010 THE PATIENT RETURNED COMPLAINING OF ANGINA. ANGIOGRAPHY SHOWED A RESTENOSIS OF THE CYPHER STENT (CXS33350/ LOT 15099041) THAT WAS PLACED IN THE MID RCA. THE LESION WAS WITHIN 5MM OF THE CYPHER STENT IN THE DISTAL RCA AS THE STENTS WERE OVERLAPPING. THE RESTENOSIS WAS TREATED WITH A CUTTING BALLOON AND PLACEMENT OF A BARE-METAL STENT.
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 | 15099041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death| H| L| R | CYPHER (CXS33300/ LOT 15111599) |