BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ-SCHATZ

    MDR report key: 128265 · Received October 24, 1997

    Report

    Report Number
    128265
    Event Type
    Injury
    Date Received
    October 24, 1997
    Date of Event
    April 21, 1997
    Report Date
    April 22, 1997
    Manufacturer
    J & J
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STENT PLACEMENT WAS ATTEMPTED DURING A COMBINED ROTOBLATOR/STENT. FOLLOWING THE ROTOBLATOR, THE DELIVERY BALLOON WITH THE UNDEPLOYED STENT WAS ADVANCED OVER THE WIRE. THE WIRE/BALLOON COMBINATION WAS MANIPULATED PRIOR TO ANY INFLATION OR DEPLOYMENT, THEN FLUORO'D. THE STENT WAS NOT VISIBLE ON THE BALLOON ANY LONGER, AND WAS NOT IDENTIFIABLE IN THE CORONARY OR ANYWHERE ELSE IN THE ASCENDING AORTA. ANGIOGRAPHY DID NOT DEMOSTRATE ITS POSITION. THE STENT COULD NOT BE IDENTIFIED ANYWHERE WITHIN THE VASCULAR TREE. THE PT WAS TRANSFERRED BACK TO THE NURSING UNIT IN STABLE CONDITION, AND HAS NOT EXHIBITED ANY UNTOWARD EFFECT FROM THE EMBOLIZED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ-SCHATZ Implant CORONARY STENT MAF J & J PS1530 125931

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening