BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3212403 · Received July 9, 2013

    Report

    Report Number
    3003742446-2013-00086
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 14, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED ASPIRIN, ATORVASTATIN CALCIUM, PLAVIX, DIOVAN, DONEPEZIL, EPTIFIBATIDE, HEPARIN, HCTZ, LISINOPRIL, LOVASTATIN, LOSARTAN, PANTOPRAZOLE, AND KCL. 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. 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 AND HYPERLIPIDEMIA. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00086 AND 3003742446-2013-00087.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(6) STUDY INDICATED THAT A PATIENT UNDERWENT REVASCULARIZATION APPROXIMATELY 39 MONTHS POST INDEX PROCEDURE. THE PATIENT HAD A PCI ON (B)(6) 2010 PRIOR TO INDEX PROCEDURE. NO INFO IS AVAILABLE. AT THE TIME OF INDEX PROCEDURE, THE PATIENT WAS ADMITTED DUE TO PREVIOUSLY DIAGNOSED LESION DURING PREVIOUS CATH. THE 1ST LESION WAS IN THE SVG DISTAL RCA DESCRIBED AS 30MM IN LENGTH, CLASS B1, SEVERELY CALCIFIED AND DE NOVO WITH 75% STENOSIS. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER. A 3.5X33MM CYPHER RX WAS IMPLANTED THAT FAILED TO CROSS THE LESION. THUS BALLOON WAS DILATED AND SAME STENT WAS SUCCESSFULLY IMPLANTED. THE 2ND LESION WAS IN THE DISTAL RCA DESCRIBED AS 20MM IN LENGTH, MODERATELY CALCIFIED, CLASS A, AND DE NOVO WITH 70% STENOSIS. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER. A 3X23MM CYPHER RX WAS IMPLANTED AT 20ATMS. THERE WERE NO PROCEDURAL COMPLICATIONS NOTED AND THE PATIENT WAS DISCHARGED A DAY LATER. APPROXIMATELY 39 MONTHS POST, PATIENT UNDERWENT REVASCULARIZATION OF THE DISTAL RCA. THE PATIENT WAS ADMITTED WITH CORONARY ATHEROSCLEROSIS. BOTH STUDY STENTS WERE RESTENOSED AND WITHIN 5MM OF NEW LESION. THE EVENT RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313971 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15077479

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention