BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK OTW VISION CORONARY STENT SYSTEM

    MDR report key: 523203 · Received April 29, 2004

    Report

    Report Number
    2024168-2004-00193
    Event Type
    Injury
    Date Received
    April 29, 2004
    Date of Event
    April 1, 2004
    Report Date
    April 5, 2004
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD FELT RESISTANCE DURING INSERTION OF THE DEVICE PROXIMALLY AND HAD FORCED THE DEVICE TO THE OM. HE COULD NOT CROSS THE LESION AND DURING REMOVAL, THE STENT WAS NO LONGER ON THE STENT DELIVERY SYSTEM. THE STENT DISLODGED IN THE VERY DISTAL PORTION OF THE CIRCUMFLEX. NO RETRIEVAL WAS ATTEMPTED AND NO ADVERSE OUTCOME WAS NOTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK OTW VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability