BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1171197 · Received September 22, 2008

    Report

    Report Number
    3003742446-2008-00174
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 28, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH A LESION IN THE DISTAL RIGHT CORONARY ARTERY. A 3.0 X 33MM CYPHER STENT DELIVERY SYSTEM (SDS) WAS BEING DELIVERED TO THE DISTAL END OF THE RIGHT CORONARY ARTERY; HOWEVER, IT COULD NOT BE DELIVERED DUE TO CALCIFICATION. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE SDS FROM THE PATIENT; HOWEVER, IT COULD NOT BE WITHDRAWN BACK INTO THE GUIDING CATHETER. ONCE THE SDS WAS BEING REMOVED FROM THE SHEATH, THE STENT DISLODGED AND EMBOLIZED INTO THE COMMON FEMORAL ARTERY. THE STENT WAS SNARED OUT USING A CONTRA-LATERAL APPROACH.

    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 13427516

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention