BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 72136 · Received February 26, 1997

    Report

    Report Number
    2247023-1997-00056
    Event Type
    Injury
    Date Received
    February 26, 1997
    Date of Event
    January 16, 1997
    Report Date
    January 29, 1997
    Manufacturer
    *
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE IN THE PATIENT'S CIRCUMFLEX ARTERY. ANGIOGRAPHY FOLLOWING SUCCESSFUL STENT PLACEMENT REVEALED A DISSECTION PROXIMAL TO THE STENT WHICH EXTENED ALONG EHE CIRCUMFLEX ARTERY AND INTO THE LEFT MAIN ARTERY. THE PATIENT WAS SUBSEQUENTLY SENT FOR CORONARY ARTERY BYPASS GRAFT SURGERY. THE SURGERY WAS SUCCESSFUL AND THERE WERE NO CLINICAL SEQUELAE REPORTED RELATIVE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM Implant CORONARY STENT WITH DELIVERY SYSTEM MAF * NA 120803

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention