BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2013448 · Received March 10, 2011

    Report

    Report Number
    2134265-2011-00655
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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

    SAME CASE AS MFR ID: 2134265-2011-00656. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL RESISTANCE OCCURRED. ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY AND 6F JL4 RUNWAY GUIDE CATHETER AND NON-BSC GUIDE WIRE WERE USED. THE 90% STENOSED, 24MM LONG AND ECCENTRIC DE NOVO LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE LESION WAS PREDILATED WITH A 2.0X12MM APEX MONORAIL BALLOON INFLATED TO 12ATM RESULTING IN 60% RESIDUAL STENOSIS. THEN A 3.0X28MM TAXUS LIBERTE MONORAIL STENT DELIVERY SYSTEM WAS ADVANCED AND DEPLOYED AT 12ATM IN THE TARGET VESSEL. FOLLOWING DEFLATION OF THE STENT DELIVERY BALLOON, AN ATTEMPT WAS MADE TO REMOVE THE DEVICE FROM THE IMPLANTED STENT AND SIGNIFICANT RESISTANCE WAS ENCOUNTERED. DIALED UP TO 2ATM AND DIALED DOWN THE BALLOON TO TRY AND RELEASE BALLOON FROM THE STENT, BUT WAS STILL UNSUCCESSFUL. WAITED AGAIN AND THEN PULLED HARD AND WAS ABLE TO REMOVE THE BALLOON INTACT. THE STENT WAS THEN POST DILATED WITH A 3.25X15MM NON COMPLIANT QUANTUM MONORAIL BALLOON WITH NO ISSUES. A NON BSC GUIDE WIRE WAS THEN USED TO CROSS A 90% STENOSED, 22MM LONG, DE NOVO AND ECCENTRIC LESION LOCATED IN THE PROXIMAL DIAGONAL WITH A REFERENCE VESSEL DIAMETER OF 3.25MM. PREDILATION WAS PERFORMED WITH A 2.0X12MM APEX BALLOON INFLATED TO 12ATM RESULTING IN 60% RESIDUAL STENOSIS. A 2.25X24MM TAXUS LIBERTE ATOM MONORAIL STENT DELIVERY SYSTEM WAS THEN ADVANCED AND THE STENT DEPLOYED AT 12ATM. WHEN WITHDRAWING THE STENT DELIVERY BALLOON, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. TO TRY AND REMOVE THE DEVICE, THE USER DIALED UP TO 2ATM AND DIALED DOWN, WAITED, PULLED HARD AND WAS ABLE TO REMOVE THE BALLOON INTACT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628300 13209010

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 3.25X15MM NC QUANTUM MONORAIL BALLOON| PILOT 50 GUIDE WIRE| 2.25X24MM TAXUS LIBERTE STENT| PROWATER FLEX GUIDE WIRE| 2.0X12MM APEX MONORAIL BALLOON| JL4 6F RUNWAY GUIDE CATHETER