BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 4825118 · Received June 8, 2015

    Report

    Report Number
    2134265-2015-03544
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    February 1, 2015
    Report Date
    May 13, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    BRAND NAME CORRECTED FROM TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM TO LIBERTÉ¿. COMMON DEVICE NAME CORRECTED FROM CORONARY DRUG-ELUTING STENT TO STENT, CORONARY. PRODUCT CODE CORRECTED FROM NIQ TO MAF. (B)(4). UPN CORRECTED FROM UNK433 TO H7493893820350. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LOCATION OF THE DAMAGE WAS <15CM FROM THE HUB, AND THAT THE SHAFT WAS NOT COMPLETELY BROKEN AND SEPARATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 70% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED TARGET VESSEL. FOLLOWING PREDILATION, A TAXUS LIBERTE STENT WAS ADVANCED TO TREAT THE LESION; HOWEVER SIGNIFICANT RESISTANCE WAS MET AND THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENCE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367929 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893820350 0015231975

    Patients

    Seq Age Sex Outcome Treatment
    1