BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001498 · Received February 19, 2008

    Report

    Report Number
    9616099-2008-00389
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    December 19, 2007
    Report Date
    January 24, 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2008-00387. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE TARGET LESION WAS THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. THE VESSEL WAS A DE-NOVO, ECCENTRIC AND BIFURCATED LESION. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE C. THE LESION LENGTH WAS 25MM AND VESSEL DIAMETER WAS 2.5-3.0MM. THE PROCEDURE WAS AN EMERGENT CASE DUE TO AN ACUTE MYOCARDIAL INFARCTION (AMI). PRE-DILATATION WAS CONDUCTED WITH A BALLOON (2.5/20MM) AT 8 ATM FOR 20 SECONDS. THE 1ST CYPHER (2.5/18MM) WAS IMPLANTED AT 16 ATM. THE 2ND CYPHER (3.0/18MM) WAS IMPLANTED AT 16 ATM PROXIMAL TO THE 1ST CYPHER OVERLAPPING IT. POST-DILATATION WAS NOT CONDUCTED. IVUS WAS NOT CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 0%. TIMI FLOW BEFORE THE PROCEDURE WAS 3 AND 3 AFTER THE PROCEDURE. IT WAS UNK WHETHER ACT WAS CONDUCTED. APPROXIMATELY THREE YEARS, A MONTH AND 17 DAYS LATER, THE PT DEVELOPED AMI. CAG WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE CYPHER. TO TREAT THE THROMBUS, ASPIRATION AND POBA WAS CONDUCTED. IN-STENT RESTENOSIS WAS ALSO OBSERVED IN A PREVIOUSLY IMPLANTED BARE METAL STENT (VISION) AT LCX AND IT WAS TREATED. THE PT RECOVERED AND WAS DISCHARGED APPROXIMATELY 3 WEEKS LATER.

    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 I1004016

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R MEDICATIONS: ASPIRIN| TICLOPIDINE HYDROCHLORIDE| HEPARIN