BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 872478 · Received March 14, 2007

    Report

    Report Number
    6000093-2007-00540
    Event Type
    Malfunction
    Date Received
    March 14, 2007
    Date of Event
    February 13, 2007
    Report Date
    February 13, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    p040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SOURCE CONFIRMED THAT THE PRODUCT HAD BEEN DISPOSED. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 9212698 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCI PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE CALCIFIED, DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH ANOTHER MANUFACTURER'S BALLOON. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH THE LIBERTE MONORAIL STENT DELIVERY SYSTEM, BUT WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO RETRACT THE STENT DELIVERY SYSTEM BACK INTO THE GUIDE CATHETER AND MET RESISTANCE. AFTER REMOVAL, IT WAS NOTED THAT A STENT STRUT WAS "LIFTED." THE PROCEDURE WAS COMPLETED WITH ANOTHER LIBERTE' STENT. PATIENT STATUS WAS LISTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 9212698

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR GUIDE CATHETER: TERUMO HEARTRAIL 2 6F JR4| BALLOONS: RYUJIN 1.25| RYUJIN 2.25