BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3213927 · Received July 9, 2013

    Report

    Report Number
    3003742446-2013-00088
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    February 25, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED ACE INHIBITORS AND PLAVIX. THE INFORMATION RECEIVED FROM THE (B)(6) STUDY INDICATED THAT THE PATIENT UNDERWENT CABG APPROXIMATELY 29 MONTH POST INDEX PROCEDURE. THE PATIENT¿S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA (WITHIN PAST 6 WEEKS), POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA (WITHIN PAST 6 WEEKS), FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF HYPERTENSION, HISTORY OF DIABETES MELLITUS, AND HEMORRHOID. AT THE TIME OF INDEX PROCEDURE, AN 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS DIAGNOSED. THE LESION WAS PRE-DILATED AND A 3.5 X 18MM CYPHER STENT WAS SUCCESSFULLY IMPLANTED. THE STENT WAS POST-DILATED PER STANDARD PROCEDURE. THERE WERE NO ANGIOGRAPHIC COMPLICATIONS OR PRODUCT MALFUNCTION. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH NO ANGINA. APPROXIMATELY 13 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT HAD A STAGED PROCEDURE TO TREAT A LESION IN THE LEFT POSTERIOR DESCENDING ARTERY AND LEFT CIRCUMFLEX THAT WAS TREATED WITH XIENCE STENT. APPROXIMATELY 29 MONTHS LATER, THE PATIENT UNDERWENT TRIPLE BYPASS SURGERY WITH VALVE REPLACEMENT. ON (B)(6) 2013, THE ANGIOGRAPHY REVEALED 60-70% STENOSIS PROXIMAL TO PREVIOUS LAD STENT. ALTHOUGH STENT WAS PATENT, THE LESION WAS WITHIN 5MM OF THE STUDY STENT. THERE WAS LUMINAL IRREGULARITIES NOTED IN MID-DISTAL LAD AND 1ST DIAGONAL. 70% STENOSIS WAS NOTED IN 2ND DIAGONAL. CIRCUMFLEX HAD OVERALL 40% STENOSIS. OVERALL RCA HAD 90% STENOSIS. THE PATIENT HAD A CABG AFTER TWO WEEKS. THE EVENT RESOLVED WITHOUT SEQUELAE AND WAS NOT RELATED TO THE STUDY STENT, DRUG OR PROCEDURE IN AN INVESTIGATOR¿S OPINION. THE STUDY STENT REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE IS NO INFORMATION REGARDING STERILE LOT IS AVAILABLE THUS NO DHR COULD BE PERFORMED. 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 IS 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 AND FAMILY HISTORY OF CAD.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B)(6) STUDY INDICATED THAT THE PATIENT UNDERWENT CABG APPROXIMATELY 29 MONTH POST INDEX PROCEDURE. THE PATIENT¿S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA (WITHIN PAST 6 WEEKS), POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA (WITHIN PAST 6 WEEKS), FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF HYPERTENSION, HISTORY OF DIABETES MELLITUS, AND HEMORRHOID. AT THE TIME OF INDEX PROCEDURE, AN 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS DIAGNOSED. THE LESION WAS PRE-DILATED AND A 3.5 X 18MM CYPHER STENT WAS SUCCESSFULLY IMPLANTED. THE STENT WAS POST-DILATED PER STANDARD PROCEDURE. THERE WERE NO ANGIOGRAPHIC COMPLICATIONS OR PRODUCT MALFUNCTION. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH NO ANGINA. APPROXIMATELY 13 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT HAD A STAGED PROCEDURE TO TREAT A LESION IN THE LEFT POSTERIOR DESCENDING ARTERY AND LEFT CIRCUMFLEX THAT WAS TREATED WITH XIENCE STENT. APPROXIMATELY 29 MONTHS LATER, THE PATIENT UNDERWENT TRIPLE BYPASS SURGERY WITH VALVE REPLACEMENT. ON (B)(6) 2013, THE ANGIOGRAPHY REVEALED 60-70% STENOSIS PROXIMAL TO PREVIOUS LAD STENT. ALTHOUGH STENT WAS PATENT, THE LESION WAS WITHIN 5MM OF THE STUDY STENT. THERE WAS LUMINAL IRREGULARITIES NOTED IN MID-DISTAL LAD AND 1ST DIAGONAL. 70% STENOSIS WAS NOTED IN 2ND DIAGONAL. CIRCUMFLEX HAD OVERALL 40% STENOSIS. OVERALL RCA HAD 90% STENOSIS. THE PATIENT HAD A CABG AFTER TWO WEEKS. THE EVENT RESOLVED WITHOUT SEQUELAE AND WAS NOT RELATED TO THE STUDY STENT, DRUG OR PROCEDURE IN AN INVESTIGATOR¿S OPINION. THE STUDY STENT REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313400 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention