BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1051386 · Received May 16, 2008

    Report

    Report Number
    2134265-2008-01434
    Event Type
    Injury
    Date Received
    May 16, 2008
    Date of Event
    January 10, 2007
    Report Date
    April 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNK, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CAUSE OF THE DIFFICULTIES STATED IN THE COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PER MAUDE EVENT REPORT, IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, PT COMPLICATIONS OCCURRED. THE PHYSICIAN IMPLANTED AN UNK SIZE EXPRESS2 STENT IN THE RIGHT CORONARY ARTERY (RCA). AN UNSPECIFIED AMOUNT OF TIME LATER, THE PT HAD OPEN HEART SURGERY WITH MITRAL VALVE REPLACEMENT WITH A MECHANICAL PROSTHESIS, AND A PACEMAKER WITH A DEFIBRILLATOR. KIDNEY FAILURE IS NOW PRESENT. NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other