BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 622666 · Received July 21, 2005

    Report

    Report Number
    9616099-2005-01218
    Event Type
    Injury
    Date Received
    July 21, 2005
    Date of Event
    June 24, 2005
    Report Date
    July 21, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THREE (3) WEEKS AFTER THE INDEX PROCEDURE THE PATIENT HAD A SUB ACUTE THROMBOSIS (SAT). THE PATIENT DID NOT DEMONSTRATE SYMPTOMS OF THE SAT. PRIOR TO DISCHARGE FROM THE HOSPITAL AFTER THE INDEX PROCEDURE, A REPEAT CATHETERIZATION WAS CONDUCTED. A 50% OCCLUSION WAS CONFIRMED. IVUS WAS DONE AND CONFIRMED THE PRESENCE OF THROMBUS. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS CONDUCTED TO TREAT THE SAT WITH A 3.0/10MM BALLOON AT 28 ATM FOR 40 SEC.THE PHYSICIANS'S COMMENTS REGARDING THE SAT WERE THAT ALTHOUGH GOOD WALL APPOSITION OF THE CYPHER STENT WAS CONFIRMED, THE VESSEL HAD PLAQUE ALL AROUND THE CIRCUMFERENCE OF THE VESSEL. THE TARGET LESION WAS ALSO RICH WITH PLAQUE AND THEREFORE AT PARTS OF THE VESSEL, THE IMPLANTED CYPHER STENT'S DIAMETER WAS ONLY 2.5MM. THE THROMBUS PROBABLY FORMED AT THAT LOCATION LEADING TO THE SAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ CORDIS DE MEXICO NA UK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R