BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ-SCHATZ BALLOON-EXPANDABLE

    MDR report key: 40367 · Received September 26, 1996

    Report

    Report Number
    2247023-1996-00035
    Event Type
    Injury
    Date Received
    September 26, 1996
    Date of Event
    August 13, 1996
    Report Date
    August 27, 1996
    Manufacturer
    CORONARY STEM WITH DELIVERY SYSTEM
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO ON A MEDICAL DEVICE REGISTRATION FORM INDICATED THAT ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM DISTAL TO AN EXISTING STENT IN THE SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL BRANCH RESULTED IN EMBOLIZATION OF THE STENT. THE DELIVERY SYSTEM WAS WITHDRAWN AND A SECOND GUIDEWIRE WAS USED TO ASSIST IN THE RETRIEVAL OF THE EMBOLIZED STENT. WHEN THE GUIDEWIRES WERE WITHDRAWN, THE STENT WAS NOTED TO HAVE EMBOLIZED PERIPHERALLY. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ-SCHATZ BALLOON-EXPANDABLE Implant STENT WITH DELIVERY SYSTEM MAF CORONARY STEM WITH DELIVERY SYSTEM NA 108456

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention