BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1210621 · Received October 23, 2008

    Report

    Report Number
    9616099-2008-02513
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 15, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT WAS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES.

    Description of Event or Problem · 1

    THREE YEARS AFTER HAVING A CYPHER STENT PLACED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) THE PT RETURNED TO THE HOSPITAL WITH CHEST PAIN. A CORONARY ANGIOGRAM REVEALED THROMBUS IN THE PREVIOUSLY PLACED CYPHER STENT. THE PT IS A MALE WITH A HISTORY OF ABNORMAL LIPID METABOLISM. THE TARGET LESION WAS DE NOVO, CONCENTRIC, AND OSTIAL WITH A THROMBOTIC TOTAL OCCLUSION. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE B2. THE VESSEL LENGTH WAS 20MM, AND THE VESSEL DIAMETER WAS 3.5MM. IN 2005, THE PT UNDERWENT ELECTIVE CYPHER (3.5/22MM) STENT PLACEMENT. IT WAS A DIRECT STENTING IN WHICH THE STENT DELIVERY SYSTEM (SDS) WAS INFLATED SEVERAL TIMES AT 22 ATMOSPHERES (ATMS) FOR A TOTAL OF 60 SECONDS. POST-DILATION WAS CONDUCTED WITH A BALLOON (3.75/15MM) AT 24 ATM FOR 3 SECONDS. IVUS WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 0. TIMI FLOW BEFORE THE PROCEDURE WAS 0, AND 3 AFTER THE PROCEDURE. ACT WAS MEASURED AND IT WAS 301 SECONDS. APPROX THREE YEARS LATER THE PT RETURNED TO THE HOSPITAL WITH CHEST PAIN. A CORONARY ANGIOGRAM WAS CONDUCTED, AND THE THROMBUS WAS OBSERVED INSIDE THE PREVIOUSLY IMPLANTED CYPHER IN THE PROXIMAL LAD. TO TREAT THE THROMBUS, ASPIRATION WAS PERFORMED, AND INTRACORONARY INFUSION OF A THROMBOLYTIC AGENT (ALTEPLASE: 6 MILLION U) WAS CONDUCTED, HOWEVER IT WAS NOT EFFECTIVE. IVUS WAS PERFORMED, AND THE PHYSICIAN FOUND THE VESSEL DIAMETER WHERE THE CYPHER WAS IMPLANTED HAD INCREASED UP TO 6.0MM DUE TO POSITIVE REMODELING. THE IMPLANTED STENT WAS ALSO FOUND TO BE UNDER-DILATED. POBA WAS COMPLETED WITH A 4.0MM BALLOON AND TIMI FLOW RECOVERED FROM 1 TO 3 FOLLOWING THE PROCEDURE. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THE POSITIVE REMODELING AND UNDER-DILATION OF THE STENT. THE DEFINITE CAUSE OF THE POSITIVE REMODELING WAS UNK HOWEVER IT COULD POSSIBLY BE CAUSED BY ALLERGY TO COATING MATERIALS USED FOR STENT OR THE PT'S CONSTITUTION.

    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 I0705032

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R