BEUDAMED
    FDA Adverse Event Death Summary report: N

    BX SONIC STENT DELIVERY SYSTEM (OUS RX)

    MDR report key: 776227 · Received November 1, 2006

    Report

    Report Number
    9616099-2006-01221
    Event Type
    Death
    Date Received
    November 1, 2006
    Date of Event
    March 26, 2004
    Report Date
    November 1, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AN AUTOPSY WAS NOT PERFORMED. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE DAY AFTER THE INDEX PROCEDURE THE PATIENT EXPERIENCE A NON Q-MI RELATED TO THE TARGET VESSEL AND THEN SUDDENLY DIED. THE DEATH WAS CLASSIFIED AS CARDIAC. IN 2004, THE PATIENT WAS ADMITTED INTO THE CATH LAB WHERE ANGIOGRAPHY REVEALED 2-VESSLE DISEASE. THE FIRST LESION WAS A 90% STENOSED TYPE B1 MID LEFT ANTERIOR DESCENDING. THE LESION WAS PRE-DILATED WITH A 3.0 X 15MM BALLOON AT 4ATMS. A 3.5 X23MM BX SONIC STENT WAS PLACED AT 12 ATMS. THE SECOND LESION WAS A 90% STENOSED TYPE B1 FIRST DIAGONAL. THE LESION WAS PRE-DILATED WITH A 3.0 X 15MM BALLOON AT 6ATMS. A 3.5X 18MM BX SONIC STENT WAS PLACED AT 18 ATMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX SONIC STENT DELIVERY SYSTEM (OUS RX) CORONARY SDS/STENTS MAF CORDIS DE MEXICO NA A1003293

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death CLOPIDOGREL| CLOPIDOGREL ( LOADING DOSE)| ACE-INHIBITORS| BETA-BLOCKERS| HEPARIN (8000IU)| NITRATES| PRE-PROCEDURE MEDICATIONS INCLUDE ASA| INTRA-PROCEDURE MEDICATIONS INCLUDE ASA