BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2872273 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07726
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: AGE AT TIME OF EVENT, AGE AT TIME OF EVENT (UNIT), PATIENT SEX, WEIGHT, WEIGHT (UNIT), DESCRIBE EVENT OR PROBLEM. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL RESISTANCE OCCURRED. A 3.0 X 16 MM TAXUS LIBERTE STENT WAS ADVANCED FOR TREATMENT AND IMPLANTED IN THE RIGHT CORONARY ARTERY . THE STENT WAS FULLY DEPLOYED AND WELL APPOSED. HOWEVER AFTER THE BALLOON WAS DEFLATED, RESISTANCE WAS MET WHILE WITHDRAWING THE BALLOON FROM THE STENT AS THE BALLOON WAS STUCK TO THE STENT. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO WITHDRAW THE STENT DELIVERY SYSTEM INCLUDING AN ATTEMPT TO PULL OUT THE WHOLE SYSTEM TO RELEASE THE BALLOON. FINALLY, THE PHYSICIAN WAS ABLE TO WITHDRAW THE STENT DELIVERY SYSTEM BUT WITH DIFFICULTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 90% STENOSED, MODERATELY CALCIFIED AND SEVERELY TORTUOUS. PRE-DILATION WAS PERFORMED. THE DEVICE HAD DIFFICULTY CROSSING THE LESION. THE 3.0X16MM TAXUS LIBERTE STENT WAS DEPLOYED AT 8 ATMS. POST DILATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894016300 15048507

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR