BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BX SONIC STENT DELIVERY SYSTEM (OUS RX)

    MDR report key: 1221204 · Received November 5, 2008

    Report

    Report Number
    9616099-2008-02600
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING AN INTERVENTIONAL PROCEDURE TO TREAT A CALCIFIED LESION IN THE RIGHT CORONARY, THE BX SONIC STENT DID NOT CROSS THE LESION. THE STENT CAME OFF THE BALLOON. THERE WAS NO PT INJURY OR NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX SONIC STENT DELIVERY SYSTEM (OUS RX) CORONARY SDS/STENTS (MAF) MAF CORDIS DE MEXICO NA 13331908

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention