BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040377 · Received May 6, 2008

    Report

    Report Number
    9616099-2008-01226
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 11, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OUS CYPHER SELECT SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE US. HOWEVER, IT IS SIMILAR TO THE US CYPHER SIROLIMUS-ELUTING CORONARY STENT. 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 90% LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) BRANCH. IT WAS NOTED THAT THE VESSEL WAS TORTUOUS AND ANGULATED. THE LESION WAS PRE-DILATED WITH A 2.5MM BALLOON; HOWEVER, A 3.0 X 23MM CYPHER SELECT STENT COULD NOT CROSS THE LESION. THEN, THE PHYSICIAN USED A 3.0MM BALLOON TO PRE-DILATE, BUT THE STENT STILL COULD NOT CROSS. WHILE WITHDRAWING THE PRODUCT, THE SHAFT KINKED AND THEN BROKE, NEAR 15CM FROM THE PROXIMAL END (OUT OF THE BODY). THE PT WAS KEPT ON DRUG TREATMENT AND THE PROCEDURE WAS NOT CONDUCTED. THERE WAS NO REPORTED 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 DE MEXICO NA 13333571

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR