BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPAMYCIN CLINICAL 2.5 X 18MM

    MDR report key: 1002302 · Received February 22, 2008

    Report

    Report Number
    9610978-2008-00056
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    February 24, 2006
    Report Date
    January 28, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE STUDY. THE PT IS A MALE WITH A HISTORY OF PREVIOUS NON Q-WAVE MI, CVA/TIA, HYPERLIPIDEMIA, SMOKING, AND WORSENING EXERTIONAL ANGINA (CCS2). THE TARGET LESION WAS THE 1ST DIAGONAL. VESSEL DIAMETER WAS 2.5MM AND LESION LENGTH WAS 15MM. PRE-PROCEDURE STENOSIS WAS 90% AND TIMI FLOW WAS 3. THERE WAS NO CALCIFICATION OR TORTUOSITY. A BX VELOCITY 2.5 X 18MM WAS DEPLOYED AT 14ATM. POST-PROCEDURE STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE PT WAS DISCHARGED THE FOLLOWING DAY. APPROX 4 YRS AND 4 MONTHS AFTER THE INDEX PROCEDURE, THE PT WAS HOSPITALIZED FOR CHEST PAIN, VOMITING AND COLD SWEAT. THERE WERE NO ECG CHANGES OR ELEVATED CARDIAC BIOMARKERS. A CAG WAS CONDUCTED AND THERE WAS ONE-VESSEL DISEASE IN THE 1ST DIAGONAL. TROPONIN WAS NOT ABOVE THE UPPER NORMAL LEVEL. THERE WAS NO INDICATION FOR REVASCULARIZATION. THE SUBJECT WAS TREATED WITH MEDICATION AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPAMYCIN CLINICAL 2.5 X 18MM CORONARY SDS/STENTS NIQ CORDIS EUROPA, N.V. NA W0401123

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening ASPIRIN| PLAVIX