BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1051667 · Received May 21, 2008

    Report

    Report Number
    9616099-2008-01363
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    December 5, 2007
    Report Date
    April 25, 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
    GR
    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. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE MALE PT RECEIVED A 2.25 X 18MM CYPHER SELECT PLUS STENT IN THE PDA AND A 3.5 X 23MM CYPHER SELECT PLUS STENT IN THE PROXIMAL TO MID LAD. AFTER IMPLANTING THE 3.5 X 23MM STENT, INSUFFICIENT FLOW WAS NOTED. ANOTHER PROCEDURAL COMPLICATION REPORTED WAS DISTAL EMBOLIZATION OF THROMBUS AND/OR PLAQUE MATERIAL. POST PROCEDURE, THE PT HAD AN ANTERIOR TARGET VESSEL RELATED Q-WAVE MI. PT WAS TREATED WITH ADENOSINE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention HEPARIN| ASPIRIN| CLOPIDOGREL