BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001520 · Received February 20, 2008

    Report

    Report Number
    9616099-2008-00411
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 25, 2008
    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 TARGET LESION WAS PROXIMAL RIGHT CORONARY ARTERY. THE VESSEL WAS A DE NOVO, FLEXED AND TOTALLY OCCLUDED LESION. THE LESION LENGTH WAS 20MM AND VESSEL DIAMETER WAS 2.5MM. AHA/ACC CLASSIFICATION OF THE VESSEL WAS A TYPE B2. THE PROCEDURE WAS AN EMERGENT CASE DUE TO ACUTE MYOCARDIAL INFARCTION. PRE-DILATION WAS CONDUCTED WITH A BALLOON (2.5/20MM: RYUJIN) AT 9ATM FOR 30SECONDS. CYPHER (2.5/23MM) WAS IMPLANTED AT 14ATM FOR 30SECONDS. POST-DILATION WAS NOT CONDUCTED. TIMI FLOW BEFORE THE PROCEDURE WAS 0 AND 3 AFTER THE PROCEDURE. IVUS WAS NOT CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 0%. ACT WAS NOT MEASURED. TWO TO THREE HOURS AFTER CYPHER IMPLANT, ECG ABNORMALITY WAS OBSERVED AND SO CAG WAS CONDUCTED. THROMBUS WAS OBSERVED AT THE PROXIMAL TO INSIDE OF THE CYPHER. TO TREAT THE THROMBUS, ASPIRATION AND POBA WITH A BALLOON (2.5/23MM: PRE-STAGE MAGNA) WAS CONDUCTED. TWO BMS (2.5/24MM, 2.5/18MM: MICRO DRIVER) WERE IMPLANTED AT THE PROXIMAL TO INSIDE OF THE IMPLANTED CYPHER. PROCEDURE DETAILS WERE ALL UNKNOWN. TWO TO THREE HOURS AFTER THROMBUS TREATMENT, ECG ABNORMALITY WAS OBSERVED AGAIN. A CAG WAS CONDUCTED AND THROMBUS WAS OBSERVED AGAIN INSIDE OF THE IMPLANTED CYPHER. TO TREAT THE THROMBUS, POBA WAS CONDUCTED WITH A BALLOON (2.75/20MM: RYUJIN). THE PROCEDURE WAS FINISHED. PROCEDURE DETAILS WERE ALL UNKNOWN. THE PATIENT IS STILL HOSPITALIZED BUT THE CONDITION WAS IN STABLE.

    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 13317390

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R CLOPIDOGREL| MEDICATION: ASPIRIN| HEPARIN