BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021038 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00724
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    May 31, 2007
    Report Date
    November 25, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT WAS RECEIVED THAT A PATIENT EXPERIENCED A LATE THROMBOTIC EVENT AND A Q-WAVE INFERO-LATERAL MYOCARDIAL INFARCTION. THE PATIENT'S HISTORY IS SIGNIFICANT FOR HYPERTENSION, DIABETES, PREVIOUS NON Q-WAVE MI, SMOKING AND STABLE AND UNSTABLE ANGINA PECTORIS. THE TARGET VESSEL WAS THE LEFT CIRCUMFLEX ARTERY (LCX) TO THE FIRST OBTUSE MARGINAL (OM). THE LESION WAS THE BIFURCATION OF THE LCX AND THE 1ST OM. T-STENTING TECHNIQUE WAS USED FOR THE BIFURCATION. THE LCX WAS PRE-DILATED AND THEN A 28MM X 3.0MM CYPHER WAS DEPLOYED IN THE MAIN BRANCH OF THE LCX. THE STENT WAS NOT POST-DILATED AND IT WAS THE PHYSICIAN'S DECISION TO NOT PERFORM KISSING BALLOON. THE 1ST OM WAS PRE-DILATED AND HAD A RESIDUAL STENOSIS OF 70%. AGAIN KISSING BALLOON WAS NOT PERFORMED PER THE PHYSICIAN'S DECISION. OM STENTING WAS NECESSARY FOR RESIDUAL STENOSIS OF GREATER THAN 50%. A 2.5MM X 13M CYPHER STENT WAS DEPLOYED IN THE 1ST OM. KISSING BALLOON, POST-DILATION AND IVUS WERE NOT PERFORMED. APPROXIMATELY SIX MONTHS LATER THE PATIENT EXPERIENCED AN INFERO-LATERAL Q WAVE MI. CAG WAS PERFORMED AND LATE STENT THROMBOSIS WAS OBSERVED OCCLUSION OF LCX AND 1ST OM. THE EVENT WAS TREATED WITH POBA ONLY. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS NOT CONDUCTED, AS THE LOT NUMBERS FOR THE INVOLVED DEVICES WERE NOT PROVIDED. THROMBOTIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. SMOKING AND DIABETES ARE FACTORS THAT LEAD TO INCREASED RISK OF ADVERSE EVENTS OCCURRING. LESION CHARACTERISTICS SUCH AS BIFURCATIONS AND THE TECHNIQUES THAT ARE USED TO TREAT SUCH LESIONS ARE FACTORS THAT CAN CONTRIBUTE TO ADVERSE EVENTS ASSOCIATED WITH THESE TYPES OF LESIONS. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL AND/OR PATIENT FACTORS AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THIS EVENT. THIS IS ONE OF TWO PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MANUFACTURING REPORTS #: 9616099-2008-00724 AND 9616099-2008-00725. PLEASE NOTE: DEVICE (LOT# UNK) IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT.

    Description of Event or Problem · 1

    THIS IS AN INITIAL AND FINAL REPORT. THE INFORMATION RECEIVED FROM THE CACTUS STUDY INDICATES THAT DURING THE 6 MONTH FOLLOW-UP THE PATIENT SUFFERED A INFERIOR/LATERAL Q-WAVE MYOCARDIAL INFARCTION. AN ANGIOGRAM WAS PERFORMED AND SHOWED LATE STENT THROMBOSIS WITH OCCLUSION OF THE MAIN AND SIDE BRANCHES. REVASCULARIZATION OF THE TARGET LESION WAS DONE WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA).

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R