BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1161256 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02235
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    March 7, 2008
    Report Date
    August 20, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS CONTRIBUTED IN THE UNITED STATES. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT #S 9616099-2008-02234, 9616099-2008-02236.

    Description of Event or Problem · 1

    ONE YEAR AFTER HAVING TWO STENTS PLACED IN THE RIGHT CORONARY ARTERY (RCA), THE PT FELT PROGRESSIVE ANGINA. AN EKG SHOWED NO CHANGES. A CORONARY ANGIOGRAPHY WAS PERFORMED AND SHOWED A NEW LESION (70%) IN THE MIDDLE SEGMENT OF RCA AND FOCAL RESTENOSIS IN THE CYPHER STENT PREVIOUSLY IMPLANTED IN DISTAL RCA (BIFURCATION). THE PT IS A FEMALE. MEDICAL HISTORY INCLUDES HYPERTENSION, HYPERLIPIDEMIA, AND DIABETES MELLITUS. THE MIAN INDICATION FOR THE INTERVENTION WAS STABLE ANGINA. THE PATIENT'S HEART RATE AT THE BEGINNING OF THE PROCEDURE WAS 47 BEATS/MIN. THE BLOOD PRESSURE WAS 130/70 MMHG. THE LVEF WAS ESTIMATED TO BE BETWEEN GREATER THAN 50%. THE TARGET LESION'S WERE LOCATED IN THE DISTAL RCA AND THE POSTERIOR DESCENDING ARTERY (PDA). THE VESSEL DIAMETER WAS 2.9 MM AND THE LENGTH WAS 25MM. THE RATE OF STENOSIS WAS 90%. THE LESION WAS RESTENOTIC AS THERE WAS A RESTENOSIS OF A PREVIOUSLY PLACED BARE-METAL STENT (LIBERTE 2.75X20). THE LESION LOCATION WAS AT THE BIFURCATION AND REQUIRED A DOUBLE GUIDEWIRE TECHNIQUE. THE VESSEL WAS VERY TORTUOUS AND CALCIFICATION WAS MODERATE. THERE WAS NO THROMBUS PRESENT AT THE TARGET SITE. THE LESION WAS PRE-DILATED WITH A 3MM X 30MM BALLOON AT 12 ATMOSPHERES (ATMS). A CYPHER WAS SUCCESSFULLY IMPLANTED AT THE BIFURCATION AND POST-DILATED WITH A 3MM X 30MM BALLOON AT 12 ATMS. THERE WERE NO COMPLICATIONS. THE NEXT TREATED SEGMENT WAS THE MID RCA. THE VESSEL DIAMETER WAS 3.6MM AND THE LENGTH WAS 22 MM. THE RATE OF STENOSIS WAS 75%. THE LESION WAS ALSO RESTENOTIC AS THERE WAS A RESTENOSIS OF A PREVIOUSLY PLACED BARE-METAL STENT (BX SONIC 3.5X33/LOT UNKNOWN). THE VESSEL WAS VERY TORTUOUS AND CALCIFICATION WAS MODERATE. THERE WAS NO THROMBUS PRESENT AT THE TARGET SITE. THE LESION WAS PRE-DILATED WITH A 3.5MMX30MM BALLOON AT 14 ATMS. A CYPHER WAS SUCCESSFULLY IMPLANTED. THE STENT WAS NOT POST-DILATED. THERE WERE NO COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. ONE YEAR LATER, THE PT RETURNED WITH CHEST PAIN. AN EKG SHOWED NO CHANGES. A CORONARY ANGIOGRAPHY WAS PERFORMED AND SHOWED A NEW LESION (70%) IN THE MIDDLE SEGMENT OF RCA AND FOCAL RESTENOSIS IN THE CYPHER STENT PREVIOUSLY IMPLANTED IN DISTAL RCA (BIFURCATION). ANGIOPLASTY AND A PROMUS STENT (3.5X28MM) WAS PLACED IN THE DISTAL LESION (WITH BIFURCATION TREATMENT) AND A PROMUS STENT (4.0X28MM) WAS PLACED IN THE MIDDLE SEGMENT WITH OPTIMAL ANGIOGRAPHIC AND ULTRASOUND RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA I1106197

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R