BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1083445 · Received July 29, 2008

    Report

    Report Number
    2134265-2008-02119
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE PHYSICIAN PRE-DILATED THE HIGHLY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY LESION WITH A MAVERICK BALLOON. THE PHYSICIAN ATTEMPTED TO PLACE A 4.00X28MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE LAD LESION, BUT COULD NOT CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE STENT DELIVERY SYS (SDS) OUT, BUT THE STENT BECAME DISLODGED FROM THE BALLOON CATHETER. THE PHYSICIAN THEN "INFLATED THE BALLOON TO LOW PRESSURE TO CAPTURE THE PROXIMAL EDGE OF THE STENT". AS THE PHYSICIAN COMPLETED THE LOW INFLATION, HE NOTED THAT THE "STENT BECAME SLIGHTLY FLARED". THE PHYSICIAN THEN TRIED TO "ADVANCE THE GUIDE CATHETER OVER THE STENT, BUT WAS UNABLE TO DO, SO DUE TO THE FLARE ON THE PROXIMAL EDGE OF THE STENT". THE PHYSICIAN THEN DECIDED TO PULL BACK THE ENTIRE GUIDE CATHETER/STENT DELIVERY SYS TO COMPLETELY REMOVE IT FROM THE PT. AS THE PHYSICIAN REACHED DOWN TO THE FEMORAL ARTERY, THE "STENT EMBOLIZED OFF THE DELIVERY CATHETER AND BECAME LODGED IN THE FEMORAL ARTERY". THE PHYSICIAN CONSULTED THE RADIOLOGY TEAM TO DECIDE IF THE STENT COULD BE SNARED OUT. THE PHYSICIAN THEN DECIDED TO LEAVE THE STENT INSIDE THE PT BECAUSE AS THE FLOW WAS NOT COMPROMISED AND THEY DID NOT FEEL THAT THE STENT WOULD EMBOLIZE FURTHER. THE LAD LESION WAS NEVER STENTED AND THE PT DID NOT COME BACK TO COMPLETE THE PROCEDURE. PT CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 4.00X28MM 11006299

    Patients

    Seq Age Sex Outcome Treatment
    1 Other