BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1437659 · Received April 13, 2009

    Report

    Report Number
    9616099-2009-00517
    Event Type
    Malfunction
    Date Received
    April 13, 2009
    Date of Event
    March 19, 2009
    Report Date
    March 19, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MFR REPORT NUMBER IS 961609-2009-00518. ADDITIONAL INFO WILL BE SUBMITTED UPON RECEIPT.

    Description of Event or Problem · 1

    AN AFFILIATE REPORTED THAT THE HUB OF TWO 2.5 X 13MM CYPHER SELECT PLUS WERE FOUND TO BE CRACKED AND LEAKING PRIOR TO USE ON A PT. THE DEVICES APPEARED NORMAL WHEN THEY WERE REMOVED FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH A XIENCE STENT DELIVERY SYSTEM.

    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 14065288

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK