BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1002599 · Received February 8, 2008

    Report

    Report Number
    3003742446-2008-00015
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 18, 2008
    Manufacturer
    CORDIS LLC PR
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR TESTING AND EVAL, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADD'L INFO REC'D WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING AN INTERVENTIONAL PROCEDURE, THE PROD DID NOT CROSS THE LESION AND THE STENT STRUTS BECAME FLARED. THERE WAS NO PT INJURY.

    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 13322991

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK