BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1973869 · Received January 31, 2011

    Report

    Report Number
    3003742446-2011-00046
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    October 25, 2010
    Report Date
    March 4, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF FOUR PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 3003742446-2011-00043, 3003742446-2011-00044, 3003742446-2011-00045, & 3003742446-2011-00046. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF FOUR PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 3003742446-2011-00043, 3003742446-2011-00044, 3003742446-2011-00045, & 3003742446-2011-00046. THE COMPLAINT RECEIVED STATES THAT THIS DAPT STUDY PATIENT SUFFERED INSTENT RESTENOSIS. THIS (B)(6) WHITE MALE IS CURRENTLY PARTICIPATING IN THE DAPT TRIAL. PATIENT MEDICAL HISTORY INCLUDES HYPERTENSION, DIABETES MELLITUS (CONTROLLED WITH ORAL MEDICATIONS), HISTORY OF PREVIOUS CABG (2009) AND HISTORY OF PREVIOUS PCI (2009). IN (B)(6) 2010, DUE TO STABLE ANGINA, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH DEPLOYMENT OF FOUR CYPHER DRUG ELUTING STENTS TO THE MID LAD. POST PROCEDURE RESIDUAL STENOSIS WAS 0% AND TIMI III FLOW. THE PATIENT RECEIVED A PERI-PROCEDURAL LOADING DOSE OF CLOPIDOGREL 300 MG. THE DAY AFTER THE INDEX PROCEDURE, THE PATIENT WAS STARTED ON CLOPIDOGREL 75 MG. ASPIRIN 325 MG DOSING WAS STARTED ON AN UNKNOWN DATE. THE PATIENT WAS DISCHARGED FROM THE INDEX PROCEDURE HOSPITALIZATION THE DAY AFTER THE INDEX PROCEDURE. IN (B)(6) 2010, THE PATIENT STARTED COMPLAINING OF HAVING ANGINA. THE PATIENT WAS ADMITTED WITH THE DIAGNOSIS OF IN-STENT RESTENOSIS WITH STABLE ANGINA PECTORIS. CORONARY ARTERIOGRAPHY REVEALED AN 80% IN-STENT RESTENOSIS IN THE LEFT MAIN. THE MID LAD STENTS WAS SUBTOTALLY OCCLUDED. PTCA WAS PERFORMED TO THE IN-STENT RESTENOSIS OF THE LEFT MAIN, WITH A 3.5 MM ANGIOSCOPE INFLATED TO 16 ATMOSPHERES. THE IN-STENT RESTENOSIS NOTED IN THE MID LAD WAS TREATED WITH A 2.5 X 15 MM ANGIOSCOPE INFLATED TO 10 ATMOSPHERES. THIS WAS FOLLOWED BY THE DEPLOYMENT OF A 2.5 X 12 MM DRUG ELUTING STENT TO THE DISTAL STENT EDGE OF THE PREVIOUS MID LAD STENT. THE EVENT WAS REPORTED AS RESOLVED AND THE PATIENT WAS DISCHARGED THE NEXT DAY. THE INDEX CYPHER STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. (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 15090761 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 15088659 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 15116877 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 15091551 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. 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 DIABETES.

    Description of Event or Problem · 1

    THE PATIENT HAD RESTENOSIS IN HIS IMPLANTED CYPHER STENTS. THE (B)(6) WHITE MALE IS CURRENTLY PARTICIPATING IN THE DAPT TRIAL. ON (B)(6) 2010, DUE TO STABLE ANGINA, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH DEPLOYMENT OF FOUR CYPHER DRUG ELUTING STENTS TO THE MID LAD. POST PROCEDURE RESIDUAL STENOSIS WAS 0% AND TIMI III FLOW. ON (B)(6) 2010, THE PATIENT RECEIVED A PERI-PROCEDURAL LOADING DOSE OF CLOPIDOGREL 300 MG. ON (B)(6) 2010, THE PATIENT WAS STARTED ON CLOPIDOGREL 75 MG. ASPIRIN 325 MG DOSING WAS STARTED ON AN UNKNOWN DATE. THE PATIENT WAS DISCHARGED FROM THE INDEX PROCEDURE HOSPITALIZATION ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT HAD STARTED COMPLAINING OF HAVING SYMPTOMS OF ANGINA. THE PATIENT WAS ADMITTED ON (B)(6) 2010 WITH THE DIAGNOSIS OF IN-STENT RESTENOSIS WITH STABLE ANGINA PECTORIS. CORONARY ARTRIOGRAPHY REVEALED AN 80% IN-STENT RESTENOSIS IN THE LEFT MAIN. THE MID LAD STENTS WAS SUBTOTALLY OCCLUDED. ON (B)(6) 2010, PTCA WAS PERFORMED TO THE IN-STENT RESTENOSIS OF THE LEFT MAIN, WITH A 3.5 MM ANGIOSCOPE INFLATED TO 16 ATMOSPHERES . THE IN-STENT RESTENOSIS NOTED IN THE MID LAD WAS TREATED WITH A 2.5 X 15 MM ANGIOSCOPE INFLATED TO 10 ATMOSPHERES. THIS WAS FOLLOWED BY THE DEPLOYMENT OD A 2.5 X 12 MM DRUG ELUTING STENT TO THE DISTAL STENT EDGE OF THE PREVIOUS MID LAD STENT. THE EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED THE NEXT DAY.

    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 15090761

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R ASPIRIN, CLOPIDOGREL