BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1230529 · Received November 12, 2008

    Report

    Report Number
    3003742446-2008-00260
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 2, 2006
    Report Date
    October 21, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO STERILE LOT NUMBER WAS PROVIDED THUS NO DHR COULD BE PERFORMED. MI AND STENT THROMBOSIS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENT IMPLANTATION AND ARE LISTED IN THE PRODUCT IFU (INSTRUCTIONS FOR USE) AS SUCH. REVIEW OF THE SEVERELY LIMITED INFORMATION DOES NOT SUGGEST WHAT FACTORS MAY HAVE CONTRIBUTED TO THE MI AND PRESUMED STENT THROMBOSIS.

    Description of Event or Problem · 1

    REPORT WAS RECEIVED REGARDING POTENTIAL LEGAL ACTION INVOLVING A PRESUMED STENT THROMBOSIS AND MI (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 AN UNKNOWN CORONARY ARTERY OF A MALE PATIENT AND SUBSEQUENTLY THE PATIENT SUFFERED AN MI AND A PRESUMED STENT THROMBOSIS. THE STENT IS UNAVAILABLE FOR ANALYSIS AND NO STERILE LOT NUMBER WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R