BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 53714 · Received December 3, 1996

    Report

    Report Number
    2247023-1996-00114
    Event Type
    Injury
    Date Received
    December 3, 1996
    Date of Event
    November 1, 1996
    Report Date
    November 5, 1996
    Manufacturer
    CORDIS, A JOHNSON & JOPHNSON CO.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE IN THE PT'S ILIAC ARTERY. A SECOND ENDOVASCULAR STENT WITH DELIVERY SYSTEM WAS ADVANCED PROXIMALLY ADJACENT TO THE DEPLOYED STENT AT THE TARGET LESION SITE. UPON INITIAL INFLATION ATTEMPT, THE DELIVERY BALLOON RUPTURED AT 6.5 ATMOSPHERES. DIAGNOSTIC ARTERIOGRAPHY SHOWED ADEQUATE ANTEGRADE BLOOD FLOW WHICH WAS FELT TO BE INDICATIVE OF FULL STENT DEPLOYMENT. SIX HOURS SUBSEQUENT, LOWER EXTREMITY PAIN AND A PULSELESS RIGHT FOOT WAS REPORTED. A REPEATED DIAGNOSTIC ARTERIOGRAPHY REVEALED AN AREA OF BLOOD FLOW OBSTRUCTION IN THE STENTED EXTREMITY. A MECHANICAL SNARE WAS UTILIZED TO SUCCESSFULLY RETRIEVE AN EMBOLIZED BALLOON FRAGMENT. THERE WERE NO ADD'L CLINICAL SEQUEALAE REPORTED RELATIVE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM Implant ENDOVASCULAR STENT WITH DELIVERY SYSTEM MAF CORDIS, A JOHNSON & JOPHNSON CO. NA 103577

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention