BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1885095 · Received October 28, 2010

    Report

    Report Number
    2134265-2010-05009
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE (OTW) STENT DELIVERY SYSTEM (SDS) WITH NO STENT. CONTRAST WAS VISIBLE IN THE DISTAL AND MIDSHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS USED. THE SDS WAS VISUALLY, TACTUALLY AND MICROSCOPICALLY EXAMINED WHICH PRESENTED NO DAMAGE OR IRREGULARITIES. THE BALLOON WAS LOOSELY FOLDED AND STENT IMPRESSIONS WERE STILL VISIBLE ON THE SURFACE OF THE BALLOON BETWEEN THE MARKERBANDS. THE KINETIX GUIDE WIRE RETURNED AS PART OF THE RELATED COMPLAINT WAS PREPPED PER THE DIRECTIONS FOR USE (DFU) AND THE SDS WAS LOADED OVER THE GUIDE WIRE WITH NO UNUSUAL FORCE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR #S 2134265-2010-04889, 2134265-2010-05008. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, WITHDRAWAL RESISTANCE OCCURRED. THE 80-85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A KINETIX GUIDEWIRE WAS PLACED IN THE LESION AND THEN A 2.75X20MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND SUCCESSFULLY DEPLOYED. WHILE REMOVING THE SDS OVER THE WIRE IT WAS NOTED THAT SYSTEMS BECAME 'GUMMY' AND THE PHYSICIAN EXPERIENCED DIFFICULTY WITHDRAWING THE SDS. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THEN A 3.0X8MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED OVER THE KINETIX GUIDEWIRE FOR POST DILATION. AFTER INFLATION OF THE BALLOON, THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED FROM THE PATIENT AS A SYSTEM. ONCE OUTSIDE THE PATIENT, THE PHYSICIAN FELT RESISTANCE WHILE TRYING TO REMOVE THE BALLOON CATHETER FROM THE WIRE; HOWEVER, THE DEVICES WERE ABLE TO BE SEPARATED. IT WAS NOTED THAT THE PHYSICIAN FELT RESISTANCE ON THE LAST 100CM OF THE GUIDEWIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION IS OKAY.

    Description of Event or Problem · 1

    SAME CASE AS MFR # 2134265-2010-04889, 2134265-2010-05008. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE WITHDRAWAL RESISTANCE OCCURRED. THE 80-85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A KINETIX GUIDEWIRE WAS PLACED IN THE LESION AND THEN A 2.75X20MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND SUCCESSFULLY DEPLOYED. WHILE REMOVING THE SDS OVER THE WIRE IT WAS NOTED THAT SYSTEMS BECAME "GUMMY" AND THE PHYSICIAN EXPERIENCED DIFFICULTY WITHDRAWING THE SDS. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THEN A 3.0X8MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED OVER THE KINETIX GUIDEWIRE FOR POST DILATION. AFTER INFLATION OF THE BALLOON, THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED FROM THE PATIENT AS A SYSTEM. ONCE OUTSIDE THE PATIENT, THE PHYSICIAN FELT RESISTANCE WHILE TRYING TO REMOVE THE BALLOON CATHETER FROM THE WIRE; HOWEVER, THE DEVICES WERE ABLE TO BE SEPARATED. IT WAS NOTED THAT THE PHYSICIAN FELT RESISTANCE ON THE LAST 100CM OF THE GUIDEWIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION IS OKAY.

    Description of Event or Problem · 1

    SAME CASE AS MFR # 2134265-2010-04889, 2134265-2010-05008. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE WITHDRAWAL RESISTANCE OCCURRED. THE 80-85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A KINETIX GUIDEWIRE WAS PLACED IN THE LESION AND THEN A 2.75X20MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND SUCCESSFULLY DEPLOYED. WHILE REMOVING THE SDS OVER THE WIRE IT WAS NOTED THAT SYSTEMS BECAME "GUMMY" AND THE PHYSICIAN EXPERIENCED DIFFICULTY WITHDRAWING THE SDS. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THEN A 3.0X8MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED OVER THE KINETIX GUIDEWIRE FOR POST DILATION. AFTER INFLATION OF THE BALLOON, THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED FROM THE PATIENT AS A SYSTEM. ONCE OUTSIDE THE PATIENT, THE PHYSICIAN FELT RESISTANCE WHILE TRYING TO REMOVE THE BALLOON CATHETER FROM THE WIRE; HOWEVER, THE DEVICES WERE ABLE TO BE SEPARATED. IT WAS NOTED THAT THE PHYSICIAN FELT RESISTANCE ON THE LAST 100CM OF THE GUIDEWIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION IS OKAY.

    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 H7493893720270 13431137

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 3.00X8MM NC QUANTUM APEX BALLOON CATHETER| KINETIX GUIDEWIRE| MACH 1 GUIDE CATHETER