BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1161266 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02239
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 23, 2008
    Report Date
    August 25, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PRECISE STENT. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE NOTIFICATION RECEIVED FOR THE STUDY INDICATED THAT THE PT EXPERIENCED A NON-Q WAVE MYOCARDIAL INFARCTION ONE DAY AFTER RECEIVING A PRECISE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS MAF CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening