BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SELECT SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1022746 · Received March 27, 2008

    Report

    Report Number
    9616099-2008-00797
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO REGARDING THE TARGET SITE WAS NOTED AS THE FOLLOWING: VESSEL TORTUOSITY WITH MILD CALCIFICATION AND PRE-EXISTING CLOT. THE LESION WAS DE NOVO, TYPE B AND 18 MM IN LENGTH, WHICH WAS PREDILATED. THE PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING. HOWEVER, ANALYSIS HAS NOT BEEN COMPLETED AS OF TO DATE. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE CYPHER SIROLIMUS-ELUTING CORONARY STENTS DISTRIBUTED IN THE US.

    Description of Event or Problem · 1

    THE INTENDED PROCEDURE WAS CORONARY STENTING OF A RIGHT CORONARY ARTERY LESION. HOWEVER, DURING PREPARATION OF THE DEVICE FOR THE PROCEDURE, SALINE SOLUTION LEAKED THROUGH AND A CRACK OF THE SHAFT WAS OBSERVED. CONSEQUENTLY, ANOTHER CYPHER STENT WAS SELECTED TO SUCCESSFULLY COMPLETE STENT IMPLANTATION WITHOUT ANY ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SELECT SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT(NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK