BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083783 · Received July 24, 2008

    Report

    Report Number
    9616099-2008-01842
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOREIGN CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADDITIONAL INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH A 90% SLIGHTLY CALCIFIED, DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) BRANCH. IT WAS NOTED THAT THE VESSEL WAS SLIGHTLY TORTUOUS. THE LESION WAS PRE-DILATED, THEN A 3.0 X 18MM CYPHER STENT WAS DELIVERED AND CROSSED THE TARGET LESION. THE STENT DELIVERY SYSTEM BACKED OUT OF THE LESION. WHEN DELIVERING THE CYPHER TO THE LESION AGAIN, THE PHYSICIAN FELT SOME RESISTANCE WITHIN THE LESION. THEREFORE, HE REMOVED THE CYPHER, KEEPING THE GUIDING CATHETER ENGAGED, AND CONFIRMED THAT THE DISTAL STRUT OF THE STENT WAS FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CYPHER.

    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 13346039

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PROCEDURE: A PASSLE GUIDEWIRE| GUIDING CATHETER AND A 2.5MM BALLOON CATHETER.| THE FOLLOWING PRODUCTS WERE USED DURING THE