BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1812485 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03782
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL RESISTANCE OCCURRED. USING A RIGHT FEMORAL APPROACH, THE INDEX PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS 2.5MM MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. TREATMENT CONSISTED OF PRE-DILATION WITH AN APEX 2.0X15MM BALLOON INFLATED TO 8 ATMS FOR 10 SECONDS AND THE PLACEMENT OF A 2.5X20MM TAXUS LIBERTE STENT DEPLOYED AT 10 ATMS FOR 13 SECONDS. THE PHYSICIAN REPORTED THAT HE HAD DIFFICULTY WITHDRAWING THE LONGER STENT DELIVERY BALLOON. THE PHYSICIAN CONFIRMED THAT THE BALLOON WAS COMPLETELY DEFLATED BEFORE REMOVAL. ADDITIONAL TREATMENT IN THE MID LAD PLACED (2) 2.5X23MM PROMUS STENTS AND A 2.5X18MM NON BSC STENT UTILIZING MULTIPLE POST DILATIONS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS LISTED AS FINE.

    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 - GALWAY H7493893620250 12691643

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR PT GRAPHIX GUIDE WIRE| 2.0X15MM APEX BALLOON CATHETER| 6FR WISE GUIDE CATHETER