BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083536 · Received July 23, 2008

    Report

    Report Number
    9616099-2008-01825
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    CORDIS DE MEXICO.
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FIVE PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MFG REPORTS #9616099-2008-01822, 9616099-2008-01823, 9616099-2008-01824, 9616099-2008-01825, AND 9616099-2008-01826. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE AFFILIATE INDICATING THAT APPROX SEVEN MONTHS POST INDEX PROCEDURE, THE PT EXPERIENCED CORONARY STENT RESTENOSIS AT A TRIFURCATION INVOLVING THE LAD, 1ST AND 2ND DIAGONAL. THE RESTENOSIS WAS TREATED WITH POBA. THE INDEX PROCEDURE WAS PERFORMED IN LATE 2007. THE INDICATION FOR THE PROCEDURE WAS 90% DIFFUSE STENOSIS AT THE PROXIMAL TO MID CIRCUMFLEX, AND 90% STENOSIS AT THE PROXIMAL LAD, 1ST DIAGONAL AND 2ND DIAGONAL. THERE WAS A FUNCTIONAL TOTAL OCCLUSION AT THE DISTAL LAD AND TRIFURCATION INVOLVING THE 1ST AND 2ND DIAGONAL. THE LEFT CORONARY ARTERIES WERE NOT TORTUOUS OR CALCIFIED. TWO FIREBIRD STENTS WERE DEPLOYED AT THE PROXIMAL TO MID OBTUSE MARGINAL. A 3.0X18MM CYPHER STENT WAS DEPLOYED AT THE PROXIMAL LAD. A 2.25X 23MM AND 2.5X18MM CYPHER STENTS WERE DEPLOYED AT THE MID LAD. A 2.25X13MM CYPHER STENT WAS DEPLOYED AT THE DISTAL LAD. A 2.5X28MM CYPHER STENT WAS DEPLOYED AT THE 1ST DIAGONAL. THE RESULTS WERE SATISFACTORY.

    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 68 YR Hospitalization| R CRB 3.00X18MM| CRB 2.25X13MM| CRB 2.5X28MM| CRB 2.25X23MM