BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 968229 · Received December 19, 2007

    Report

    Report Number
    9616099-2007-02551
    Event Type
    Death
    Date Received
    December 19, 2007
    Date of Event
    November 21, 2007
    Report Date
    November 29, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS AN ELECTIVE CASE. FOR THE LM TO THE LAD, PRE-DILATATION WAS CONDUCTED WITH A BALLOON (3.0/20MM) AT 8ATM FOR 30 SECS. A CYPHER (2.5/28MM) WAS IMPLANTED AT 16ATM FOR 30 SECS AT LAD AND TAXUS (3.0/28MM) WAS IMPLANTED AT 10 ATM FOR 15 SECS. THE TWO STENTS WERE OVERLAPPING EACH OTHER. POST-DILATATION WAS CONDUCTED WITH THE EACH STENT DELIVERY SYSTEM BALLOON AT 10 ATM FOR 30 SECS. IVUS WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 0%. TIMI FLOW BEFORE THE PROCEDURE WAS 2 AND 3 AFTER THE PROCEDURE. FOR THE CFX, PRE-DILATATION WAS CONDUCTED WITH A BALLOON (3.0/20MM) AT 8ATM FOR 30 SECS. A BARE METAL STENT (S-STENT 3.0/18MM) WAS IMPLANTED AT 12ATM FOR 30 SECS. IT WAS IMPLANTED BY Y-STENT WITH TAXUS AT LM. POST-DILATATION WAS CONDUCTED. IVUS WAS CONDUCTED. THE RESIDUAL 5 OF STENOSIS WAS 0%. TIMI FLOW BEFORE THE PROCEDURE WAS 2 AND 3 AFTER THE PROCEDURE. ACT WAS NOT MEASURED. A WEEK LATER, THE PT DEVELOPED CARDIOGENIC SHOOK. HE WAS BROUGHT TO THE HOSPITAL AS AN EMERGENCY. UNDER IABP, CAG WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE TAXUS AND S-STENT. THERE MIGHT HAVE BEEN THROMBUS IN THE CYPHER. TO TREAT THE THROMBUS, ASPIRATION AND POBA WAS CONDUCTED IN ALL STENTS. THE FLOW WAS RECOVERED BUT THE PT PASSED AWAY.

    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 13299439

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| L| R DEVICES:TAXUS (3.0/28 MM)| ASPIRIN| HEPARIN| CLOPIDOGREL| BMS (S-STENT 3.0/18MM)