BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1011256 · Received March 10, 2008

    Report

    Report Number
    9616099-2008-00568
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 15, 2007
    Report Date
    February 15, 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT #9616099-2008-00567. 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 TWO CYPHER SELECT PLUS STENTS IN THE MID LEFT ANTERIOR DESCENDING (LAD). THE REPORT RECEIVED INDICATES THAT APPROXIMATELY 30 DAYS POST INDEX PROCEDURE, THE TARGET LESION WAS REPORTED AS BEING 95-99% OCCLUDED WITH IN-STENT RESTENOSIS DURING A PLANNED STAGED PROCEDURE TO TREAT A NEW LESION IN THE PROXIMAL CIRCUMFLEX.

    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 13213572

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R HMG| CLOPIDOGREL| ASPIRIN| BETA BLOCKERS