BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 798659 · Received December 20, 2006

    Report

    Report Number
    9616099-2006-01655
    Event Type
    Injury
    Date Received
    December 20, 2006
    Date of Event
    November 15, 2006
    Report Date
    November 27, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FILE HAS BEEN RE-ACCESS AS PER THE SIMILAR DEVICE REPORTABILITY CRITERIA IMPLEMENTED BY CORDIS CORPORATION ON 12/15/06. THE MDR DETERMINATION HAS CHANGED FROM NOT REPORTABLE TO A REPORTABLE EVENT, AS THE DEVICE IS CONSIDERED TO BE SIMILAR TO THE UNITED STATES PRODUCT. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS IS ONE OF TWO PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MANUFACTURING REPORTS #: 9616099-2006-01653, 961699-2006-01655. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE FOLLOWING REPORT WAS RECEIVED FROM CLINICAL STUDY: APPROXIMATELY SIX MONTHS POST INDEX PROCEDURE, THE PT WAS REVASCULARIZED. ANGIOGRAPH RESULTS CONFIRMED 90% RESTENOSIS OF THE TARGET LESION. TREATMENT FOR THIS EVENT REMAINS UNKNOWN.

    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 I0206052

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R