BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 757874 · Received August 30, 2006

    Report

    Report Number
    6000093-2006-01664
    Event Type
    Injury
    Date Received
    August 30, 2006
    Date of Event
    June 12, 2006
    Report Date
    August 3, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISCARDED BY THE HOSPITAL AND THE STENT REMAINS IMPLANTED IN THE PATIENT, THEREFORE, NO DIRECT PRODUCT ANALYSIS IS AVAILABLE. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. THE INITIAL PROCEDURE OCCURRED IN 2005. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 3.0X12MM DRUG ELUTING STENT TO THE MEDIUM IVA. DESPITE TREATMENT WITH PLAVIX, THE PATIENT PRESENTED IN 2006 WITH VIOLENT THORACIC PAIN. THE PATIENT WAS GIVEN MORPHINE, BUT THE PAIN PERSISTED AND ANGIOGRAPHY WAS PERFORMED. ANGIOGRAPHY SHOWED OCCLUSION OF THE RECENTLY IMPLANTED STENT. "THROMBOASPIRATION WITH A CATHETER, THEN REALIZATION OF ACTILYSE IN INTRA-CORONARY UNDER COVER OF REPRO AND KRENOSIN, FOLLOWED BY AN ANGIOPLASTY WITH BALLOON AND WITH AN IMPLANT OF A NAKED ENDOPROSTHESIS. A SEARCH FOR RESISTANCE TO PLAVIX IS IN PROCESS. DURING THE ECG, THEY NOTICED THE CONSTITUTION OF A WAVE Q OF V2 TO V4 AND A PERSISTENT SHIFT IN THESE SAME DERIVATIONS. THE BIOLOGICAL ASSESSMENT SHOWED A MAJOR RISE IN CPK AT 4200, AND A RATE OF TROPONINE HIGHER THAN 23." ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 3.0X12MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention