BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL ELUTING CORONARY STENT

    MDR report key: 759684 · Received September 12, 2006

    Report

    Report Number
    6000093-2006-01824
    Event Type
    Injury
    Date Received
    September 12, 2006
    Date of Event
    June 2, 2005
    Report Date
    August 17, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNK, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT IMMEDIATELY POST STENTING, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI). THE PATIENT PRESENTED FOR THE INDEX PROCEDURE WITH CHEST PAIN AND AN ABNORMAL STRESS TEST. UPON INITIAL CATHETERIZATION, THE PATIENT RECEIVED A STENT TO THE RIGHT CORONARY ARTERY. THE LESION IN THE CIRCUMFLEX WAS A DE NOVO BIFURCATED LESION BETWEEN THE 1ST POSTEROLATERAL (1ST LPL) AND A-V GROOVE BRANCH. THE VESSEL WAS 90% STENOSED AND WAS APPROXIMATELY 2.0-2.5 MM WIDE. DUE TO PATIENT CONDITIONS, THE 1ST LPL WAS ATTEMPTED THE FOLLOWING DAY. A WIRE WAS PLACED TO THE LPL WITHOUT DIFFICULTY. HOWEVER, THE PHYSICIAN WAS UNABLE TO GAIN ACCESS TO THE A-V GROOVE BRANCH. THE PHYSICIAN PROCEEDED WITH PREDILATING THE LPL AND AGAIN TRIED TO CROSS THE A-V GROOVE BRANCH, BUT COULD NOT GET THRU INITIAL STENOSIS IN THE MAIN CIRCUMFLEX. A 2.5 X 24 MM TAXUS EXPRESS2 STENT WAS THEN PLACED IN THE LPL WITH GOOD RESULTS. HOWEVER, THE A-V GROOVE BRANCH WAS NOW COMPLETELY OBSTRUCTED. INTRACORONARY NITROGLYCERIN WAS USED AND THE LESION WAS ONCE AGAIN ATTEMPTED UNSUCCESSFULLY. DURING THE VESSEL CLOSURE, THE PATIENT HAD SIGNIFICANT CHEST PAIN. AN EKG REVEALED CHANGES CONSISTENT WITH ISCHEMIA. THE PATIENT RECEIVED MORPHINE FOR CHEST PAIN. DUE TO UNSUCCESSFUL ATTEMPTS, IT WAS DECIDED THAT THE LESION WOULD BE TREATED CONSERVATIVELY. ENZYMES WERE MONITORED, AND A PEAK CK-MB OF 67 NG/ML (ULN.8) POST PROCEDURALLY WAS NOTED. TROPONIN AND CK'S WERE ALSO ELEVATED. EKG CONTNIUED TO BE CONSISTENT WITH AN NON Q WAVE MI. THE PATIENT DID WELL POST PROCEDURE AND GRADUALLY IMPROVED. THE PATIENT WAS DISCHARGED 5 DAYS POST INDEX PROCEDURE ON PLAVIX, COUMADIN, ORAL DIABETES AGENTS, BENICAR, LOTENSIN, AND TOPROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.5X24MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L