BEUDAMED
    FDA Adverse Event Injury Summary report: N

    `TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1040184 · Received May 8, 2008

    Report

    Report Number
    2134265-2008-01339
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT FELL OFF THE BALLOON. THE 85-90% STENOSED, CALCIFIED, TARGET LESION WAS IN THE MID LEFT CIRCUMFLEX (LCX) ARTERY AT THE 1ST OBTUSE MARGINAL ARTERY. THE TAKEOFF OF THE LCX WAS AT A >90 DEGREE ANGLE FROM THE LEFT MAIN ARTERY. THE LESION WAS PREDILATED WITH A 2.5X12MM MAVERICK BALLOON CATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE A 3.5X16MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT THE DEVICE WOULD NOT ADEQUATELY CROSS TO THE LESION. "WITH THE >90 DEGREE TURN, THE DEVICE WOULD MAKE THE RIGHT (1ST) TURN AND NOT THE LEFT (2ND) TURN." DURING WITHDRAWAL, IT WAS NOTICED THAT THE STENT HAD FALLEN OFF THE BALLOON INSIDE THE PT IN AN UNSPECIFIED LOCATION. ATTEMPTS TO RETRIEVE THE STENT WITH NON-BSC SNARE AS WELL AS WITH THE FACILITY'S "OWN SNARE" (REPORTEDLY, A COMBINATION OF AN UNSPECIFIED GUIDE WIRE, SNARE AND BALLOON CATHETER) WERE UNSUCCESSFUL. THE PT REQUIRED SINGLE VESSEL CORONARY ARTERY BYPASS SURGERY. THERE WERE NO ADDITIONAL PT COMPLICATIONS REPORTED WITH THE PT CURRENTLY "RECOVERING" AND "DOING FINE".

    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 3.5X16MM 0011327766

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MICORVENA SNARE| WHISPER| PROWATER AND HI-TORQUE EXTRA SUPPORT GUIDE WIRES