BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1250401 · Received December 3, 2008

    Report

    Report Number
    3003742446-2008-00272
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    December 18, 2006
    Report Date
    November 26, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT WAS RECEIVED REGARDING POTENTIAL LEGAL ACTION INVOLVING A LATE STENT THROMBOSIS AND MYOCARDIAL INFARCTION. REVIEW OF THE AVAILABLE INFORMATION DOES NOT REVEAL SUFFICIENT INFORMATION TO RELATE THE PROCEDURAL, PATIENT OR TARGET LESION DETAILS. AN UNKNOWN CYPHER STENT WAS PLACED IN THE RIGHT CORONARY ARTERY OF A MALE PATIENT AND SUBSEQUENTLY THE PATIENT SUFFERED A LATE STENT THROMBOSIS AND MI. THE INFORMATION REVEALS THE PLAVIX WAS DISCONTINUED EITHER THREE OR SIX MONTHS AFTER THE PROCEDURE. THE STENT IS UNAVAILABLE FOR ANALYSIS AND NO STERILE LOT NUMBER WAS PROVIDED. NO STERILE LOT NUMBER WAS PROVIDED THUS NO DHR COULD BE PERFORMED. STENT THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENT IMPLANTATION AND IS LISTED IN THE PRODUCT IFU (INSTRUCTIONS FOR USE) AS SUCH. REVIEW OF THE SEVERLY LIMITED INFORMATION DOES NOT SUGGEST WHAT FACTORS MAY HAVE CONTRIBUTED TO THE LATE STENT THROMBOSIS AND MI.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R