BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1031135 · Received April 18, 2008

    Report

    Report Number
    9616099-2008-01031
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 25, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE FEMALE PATIENT RECEIVED A 3.5 X 13MM CYPHER SELECT PLUS STENT IN THE PROXIMAL RCA IN 2007. IN 2008, THE PATIENT DEVELOPED PAIN IN HER LEFT SHOULDER INTO HER CHEST. ANGIOGRAPHY REVEALED OCCLUSION IN THE MID RCA. A SUCCESSFUL PCI WAS PERFORMED TO TREAT THE LESION. ON TWELVE DAYS LATER, THE PATIENT HAD ANGINA PECTORIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 13234280

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R CLOPIDOGREL| ASPIRIN