BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 794163 · Received December 11, 2006

    Report

    Report Number
    9616099-2006-01613
    Event Type
    Injury
    Date Received
    December 11, 2006
    Date of Event
    November 12, 2006
    Report Date
    December 11, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TARGET LESION WAS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE FIRST DIAGONAL BRANCH ARTERY. BOTH LESIONS WERE DE-NOVO, ECCENTRIC AND BIFURCATED LESION. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE B2. THE LAD LESION LENGTH WAS 20MM AND VESSEL DIAMETER WAS 2.5MM. FOR FIRST DIAGONAL, THE LESION LENGTH WAS 13MM AND VESSEL DIAMETER. THE PROCEDURE WAS AN ELECTIVE CASE. PRE-DILATATION WAS CONDUCTED WITH A BALLOON (2.5/20MM) AT 8ATM FOR 20 SECONDS. 1ST CYPHER (2.5/23MM) WAS IMPLANTED AT 16 ATMOSPHERES FOR 20 SECONDS AT LAD. THE SECOND CYPHER (2.5/23MM) WAS IMPLANTED AT 16 ATMOSPHERES FOR 20 SECONDS AT THE FIRST DIAGONAL BRANCH. THE TWO STENTS WERE IMPLANTED BY Y-STENTING. POST-DILATION WAS CONDUCTED WITH A BALLOON (2.5/20MM) AND WITH A SDS BALLOON (2.5/25MM)AT 6 ATMOSPHERES FOR 20 SECONDS. IVUS WAS NOT CONDUCTED. THE RESIDUAL STENOSIS WAS 25% FOR THE LAD AND 0% FOR FIRST DIAGONAL BRANCH. TIMI FLOW FOR THE PRE AND POST PROCEDURE WAS 3. ACT WAS NOT MEASURED. THE PRODUCT WILL NOT BE RETURNED FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS DEVICE, CJS23250, IS NOT DISTRIBUTED IN THE USA; HOWEVER, IT IS SIMILAR TO USA PRODUCT CXS23350.

    Description of Event or Problem · 1

    SIXTEEN MONTHS AFTER THE PROCEDURE THE PT DEVELOPED ANGINA PECTORIS AND WAS ADMITTED TO THE HOSP. ANGIOGRAPHY DEMONSTRATED THROMBUS IN THE CYPHER IMPLANTED IN THE FIRST DIAGONAL BRANCH. THE THROMBUS WAS TREATED WITH ASPIRATION AND POBA (DETAILS WERE UNKNOWN). PHYSICIAN'S COMMENT: THE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE STENTS WERE IMPLANTED BY Y-STENTING FOR THE SMALL VESSEL (FIRST DIAGNONAL BRANCH) AND THE PT HAD DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA I0405112

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R TICLOPIDINE HYDROCHLORIDE| ASPIRIN| HEPARIN