BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1181156 · Received September 30, 2008

    Report

    Report Number
    9616099-2008-02369
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 1, 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

    PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT THE CYPHER STENT AT THE DISTAL END OF THE LESION AT AHA 6 WAS UNDER-DILATED DUE TO THE HEAVY CALCIFIED VESSEL. ANOTHER POSSIBLE CAUSE WAS THAT ASPIRIN WAS NOT ADMINISTERED DUE TO THE PATIENT'S MEDICAL HISTORY OF BRAIN DISEASES. THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES, BUT IS SIMILAR TO US DISTRIBUTED STENT DELIVERY SYSTEMS. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2008-02367, 9616099-2008-02368 AND 9616099-2008-02369. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A PROCEDURE IN 2008, WITH A LESION IN THE PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING BRANCH. THE LESION WAS DE NOVO, FLEXED, PARTIALLY CONCENTRIC AND ECCENTRIC, BIFURCATED, AND CALCIFIED. IT WAS 75MM IN LENGTH AND THE VESSEL WAS 3.0MM IN DIAMETER. ROTABLATOR WAS CONDUCTED INITIALLY, AND THE LESION WAS PRE-DILATED SEVERAL TIMES. A 3.0 X 18MM CYPHER STENT WAS IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING BRANCH AT 16ATM. NEXT, A 3.0 X 28MM CYPHER STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING BRANCH, OVERLAPPING THE FIRST CYPHER, AT 16ATM. FINALLY, A 3.0 X 33MM CYPHER STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING BRANCH, OVERLAPPING THE SECOND CYPHER, AT 16ATM. THE STENTS WERE POST-DILATED AND AN INTRAVASCULAR ULTRASOUND WAS CONDUCTED. THE RESIDUAL PERCENTAGE OF STENOSIS WAS 25 AND TIMI FLOW WAS GRADE III. SEVEN DAYS POST INDEX PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN. TWO DAYS LATER THE PATIENT WENT TO THE HOSPITAL AND CORONARY ANGIOGRAPHY WAS CONDUCTED. THROMBUS WAS OBSERVED INSIDE OF THE CYPHERS THAT WERE IMPLANTED. BALLOON ANGIOPLASTY WAS CONDUCTED TO TREAT THE THROMBUS.

    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 13412029

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 2.5 X 20MM BALLOON CATHETER| 3.0 X 15MM BALLOON CATHETER