BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS 2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1250350 · Received December 3, 2008

    Report

    Report Number
    2134265-2008-04562
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025/S21
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 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, DIFFICULTY ADVANCING THE STENT DELIVERY SYSTEM OCCURRED AND THE STENT MOVED ON THE STENT DELIVERY SYSTEM BALLOON. THE LESION WAS PRE-DILATED WITH A 2.0X9MM MAVERICK BALLOON. THE PHYSICIAN ATTEMPTED TO IMPLANT A TAXUS EXPRESS2 ATOM 2.25X8MM DRUG ELUTING STENT TO THE 80% STENOSED LESION LOCATED IN THE MILDLY CALCIFIED AND SEVERELY TORTUOUS, DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, BUT HAD DIFFICULTY ADVANCING THE STENT TO THE LESION, THE PHYSICIAN THEN DECIDED TO TRY TO BRING THE STENT BACK, BUT IT FELT AS THOUGH THE STENT WAS COMING OFF OF THE BALLOON. THE STENT WAS THEN DEPLOYED IN THE LAD, JUST PROXIMAL TO THE LESION. THE PROCEDURE WAS COMPLETED BY SUCCESSFULLY PLACING TWO ADDITIONAL STENTS. NO PATIENT COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS 2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.25X8MM 11963007

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention