BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1202199 · Received October 16, 2008

    Report

    Report Number
    9616099-2008-02462
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 16, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT WAS RETURNED FOR EVAL AND TESTING; HOWEVER, THE ENGINEERING EVAL IS NOT COMPLETE. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE PRELIMINARY COMMENTS REGARDING THE RETURNED PRODUCT INDICATED THAT THE DISTAL AND PROXIMAL STENT STRUTS WERE FLARED.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE STENT DELIVERY SYSTEM (SDS) BALLOON OF THE CYPHER SELECT PLUS 3.0 X 18 MM STENT DID NOT INFLATE. THE STENT WAS NOT EXPANDED/IMPLANTED. THERE WAS NO REPORTED PT INJURY. THE REPORT STATED THE PT WAS TREATED WITH THE SAME LIKE PRODUCT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    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 13423468

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK