BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1020967 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00714
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    February 2, 2006
    Report Date
    March 24, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE (LOT I0405107) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE MALE PT RECEIVED A CYPHER SELECT STENT TO TREAT A BIFURCATED LESION IN THE LEFT CIRCUMFLEX AND THE FIRST OBTUSE MARGINAL. THE MAIN BRANCH IN THE FIRST OM HAD 80% STENOSIS AND THE SIDE BRANCH IN THE LCX HAD 80% STENOSIS. PT WAS TREATED WITH PROVISIONAL T STENTING. MAIN BRANCH WAS PREDILATED WITH A 2.25 X 12MM BALLOON AT 10 ATM A 2.5X13 MM CYPHER SELECT STENT WAS IMPLANTED AT 10ATM WITH NO POSTDILATATION. KISSING BALLOON 2.25 X 12MM (10ATM) WAS PERFORMED. FINAL STENOSIS WAS 0%. SIDE BRANCH WAS PREDILATED WITH A 2.25 X 12 BALLOON AT 16 ATM. NO POSTDILATATION WAS CONDUCTED. KISSING BALLOON 2.25 X 12MM (16 ATM) WAS CONDUCTED. FINAL STENOSIS WAS 0%. APPROXIMATELY EIGHT MONTHS POST-PROCEDURE, THE PT HAD A RE-PTCA OF THE TARGET LESION. PT HAD 90% RESTENOSIS IN THE MAIN BRANCH AND 30% OCCLUSION IN THE SIDE BRANCH. LESION WAS TREATED WITH BALLOON ANGIOPLASTY.

    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 I0405107

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R