BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDINOL LTD. STENT

    MDR report key: 226476 · Received June 7, 1999

    Report

    Report Number
    226476
    Event Type
    Injury
    Date Received
    June 7, 1999
    Date of Event
    May 5, 1999
    Report Date
    May 12, 1999
    Manufacturer
    BOSTON SCIENTIFIC CORP SCIMED LIFE SYSTEMS, INC.
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A LEFT HEART CATHERIZATION AND WAS FOUND TO HAVE SIGNIFICANT LESIONS IN THE LAD AND RCA AND A VERY LIGHT LESION IN THE CIRCUMFLEX. THE PHYSICIAN RECOMMENDED MYOCARDIAL REVASCULARIZATION BUT THE PT INSISTED ON HAVING PTCA. DURING THE ATTEMPT TO PLACE THE STENT ACROSS THE LESION, THE STENT CAME OFF AND IT WAS NOT POSSIBLE TO RETREIVE THE STENT. THE PT AGREED TO HAVE MYOCARDIAL REVASCULARIZATION PERFORMED AND WAS SENT TO THE OR. THE STENT WAS NOT FOUND. THE SURGEON BELIEVES IT MAY HAVE POPPED OUT WHEN THE CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDINOL LTD. STENT Implant NIRON RANGER PREMOUNTED STENT SYSTEM MAF BOSTON SCIENTIFIC CORP SCIMED LIFE SYSTEMS, INC. NRGR 7-32-3.5 1965042

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 3. PROVACHOL 20MG QD.| 2. ASPIRIN 81MG 1 Q.D.A.M.| 1. METOPROLOL 25MG B.I.D.