BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1101788 · Received August 5, 2008

    Report

    Report Number
    3003742446-2008-00152
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED FOR A PROCEDURE IN 2007 WITH A 75%, DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY. THE MAIN INDICATION FOR INTERVENTION WAS CHEST PAIN. A GUIDEWIRE CROSSED THE LESION AND A 3.5 X 33MM CYPHER STENT WAS IMPLANTED AT 18 ATM. THE STENT WAS POST-DILATED SEVERAL TIMES AT VARIOUS ATMOSPHERES. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE. APPROX A YR AND FOUR MONTHS POST INDEX PROCEDURE, THE PT WAS ADMITTED TO THE HOSP WITH CHEST PAIN. THE PHYSICIAN NOTED THAT THE STENT HAD BEEN INITIALLY IMPLANTED, HAD A FRACTURE AND THERE WAS 60% RESTENOSIS AND "VESSEL DISPLACEMENT" OBSERVED. THE AREA WAS TREATED WITH A 3.5MM VISION STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA A0107076

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R POWERSAIL BALLOON CATHETER.| PROCEDURE: A 6F BMW GUIDEWIRE AND A 3.75 X 8 MM| THE FOLLOWING PRODUCTS WERE USED DURING THE