BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032594 · Received April 21, 2008

    Report

    Report Number
    9616099-2008-01038
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OUS CYPHER SELECT PLUS SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITES STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADD'L INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    BEFORE DEPLOYMENT, THE STRUTS OF A 2.75 X 18MM CYPHER SELECT PLUS STENT WERE ALREADY DISTORTED. ADDENDUM: THE PATIENT WAS ADMITTED FOR A PROCEDURE ON MARCH 26, 2008 WITH A CALCIFIED LESION IN THE DISTAL CIRCUMFLEX. IT WAS NOTED THAT THE LESION WAS RESTENOTIC (2.75 X 19MM COROFLEX BARE METAL STENT). THE LESION WAS PRE-DILATED AND A 2.75 X 18MM CYPHER SELECT PLUS STENT WAS CHOSEN FOR THE PROCEDURE. THERE WAS DIFFICULTY CROSSING THE LESION. IT WAS NOTED THAT THE PROXIMAL STRUTS ON THE STENT WERE UPLIFTED. THIS WAS NOTED DURING USE. IT WAS ALSO NOTED THAT EXCESSIVE FORCE WAS USED DURING INSERTION AND WITHDRAWAL. THERE WAS NO REPORTED PATIENT INJURY.

    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 13340306

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR CATHETER.| PRODUCT: EBU MEDTRONIC GUIDING CATHETER| THE FOLLLOWING PRODUCTS WERE USED DURING THE| ABBOTT GUIDE WIRE AND 2.5 X 15MM SPRINTER BALLOON